Refine your search
Showing 7 results
Clinical Trial Manager Remote, Australia; Remote, Singapore; Remote, South Korea
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
1 day(s) ago
Clinical Trial Manager Remote, Australia; Remote, Singapore; Remote, South Korea
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
1 day(s) ago
Clinical Trial Manager
Precision for Medicine
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
2 day(s) ago
Clinical Trial Manager
Precision for Medicine
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
2 day(s) ago
Clinical Trial Lead - Oncology & Rare Disease
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision Medicine Group in Australia is hiring a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, and ICH-GCP. You will coordinate with project management on budgeting, develop study documents, manage site feasibility, and maintain QA across monitoring, IP reconciliation, and CAPA processes. The role requires 5-8 years in clinical research, a science degree, travel, and strong communication.
3 day(s) ago
Clinical Trial Lead - Oncology & Rare Disease
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision Medicine Group in Australia is hiring a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, and ICH-GCP. You will coordinate with project management on budgeting, develop study documents, manage site feasibility, and maintain QA across monitoring, IP reconciliation, and CAPA processes. The role requires 5-8 years in clinical research, a science degree, travel, and strong communication.
3 day(s) ago
Clinical Trial Manager
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
3 day(s) ago
Clinical Trial Manager
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. We are hiring for a Clinical Tria…
3 day(s) ago
Clinical Trial Lead for Oncology & Rare Disease
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision Medicine Group is seeking a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP and regulatory requirements. This role serves as the primary client contact and collaborates with PMs on budgeting, feasibility, and study documentation. You will oversee site selection, enrollment plans, data quality, and CAPA development while coordinating with CRAs, QA, and vendors to deliver timely, compliant trial results.
8 day(s) ago
Clinical Trial Lead for Oncology & Rare Disease
Precision Medicine Group
ACT
Medical Research and Biosciences
Precision Medicine Group is seeking a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP and regulatory requirements. This role serves as the primary client contact and collaborates with PMs on budgeting, feasibility, and study documentation. You will oversee site selection, enrollment plans, data quality, and CAPA development while coordinating with CRAs, QA, and vendors to deliver timely, compliant trial results.
8 day(s) ago
Remote Clinical Trial Manager - Oncology & Rare Diseases
Precision Medicine Group, LLC.
ACT
Medical Research and Biosciences
Precision for Medicine seeks a Clinical Trial Manager to lead the operational aspects of clinical studies across international sites. You will ensure adherence to protocols, SOPs, ICH-GCP, and regulatory requirements while serving as the primary point of contact for clients and study teams. You will develop essential study documents, manage budgets, coordinate site feasibility, and train CRAs/vendor staff. This role requires strong communication, travel flexibility, and collaboration with
8 day(s) ago
Remote Clinical Trial Manager - Oncology & Rare Diseases
Precision Medicine Group, LLC.
ACT
Medical Research and Biosciences
Precision for Medicine seeks a Clinical Trial Manager to lead the operational aspects of clinical studies across international sites. You will ensure adherence to protocols, SOPs, ICH-GCP, and regulatory requirements while serving as the primary point of contact for clients and study teams. You will develop essential study documents, manage budgets, coordinate site feasibility, and train CRAs/vendor staff. This role requires strong communication, travel flexibility, and collaboration with
8 day(s) ago
Clinical Trial Manager
Precision Medicine Group, LLC.
ACT
Medical Research and Biosciences
Location: Remote, Australia; Remote, Singapore; Remote, South Korea Category: Clinical Trial Services Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 7304 Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrat…
8 day(s) ago
Clinical Trial Manager
Precision Medicine Group, LLC.
ACT
Medical Research and Biosciences
Location: Remote, Australia; Remote, Singapore; Remote, South Korea Category: Clinical Trial Services Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 7304 Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrat…
8 day(s) ago
Clinical Trial Manager Remote, Australia; Remote, Singapore; Remote, South Korea
Precision Medicine Group View all jobs
Posted 1 day(s) ago
Reference: 3201597020
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager.
Position Summary:
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- When a cross functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Supports business development and marketing activities as appropriate
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- May manages workload of supervised staff with continued assessment and adjustment as needed
- Perform other duties as assigned by management
Minimum Required :
- Bachelor's degree or equivalent combination of education/experience in science or health related field. Advanced degree preferred
- Minimum of 5 8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
Other Required:
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
We use Artificial Intelligence (AI) to generate insights during the end to end application journey, including resume review and interviews . Please review our Privacy Policy - Precision Medicine Group for more information.
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Posted 2 day(s) ago
Reference: 3205789371
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager.
Position Summary:Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project-specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Supports business development and marketing activities as appropriate
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- May manages workload of supervised staff with continued assessment and adjustment as needed
- Perform other duties as assigned by management
- Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
- Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Clinical Trial Lead - Oncology & Rare Disease
Precision Medicine Group View all jobs
Posted 3 day(s) ago
Reference: 3205125608
Precision Medicine Group in Australia is hiring a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, and ICH-GCP.
You will coordinate with project management on budgeting, develop study documents, manage site feasibility, and maintain QA across monitoring, IP reconciliation, and CAPA processes.
The role requires 5-8 years in clinical research, a science degree, travel, and strong communication.
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Posted 3 day(s) ago
Reference: 3205124782
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager.
Position Summary:
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- When a cross functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Supports business development and marketing activities as appropriate
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- May manages workload of supervised staff with continued assessment and adjustment as needed
- Perform other duties as assigned by management
Minimum Required :
- Bachelor's degree or equivalent combination of education/experience in science or health related field. Advanced degree preferred
- Minimum of 5 8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
Other Required:
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
We use Artificial Intelligence (AI) to generate insights during the end to end application journey, including resume review and interviews . Please review our Privacy Policy - Precision Medicine Group for more information.
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Clinical Trial Lead for Oncology & Rare Disease
Precision Medicine Group View all jobs
Posted 8 day(s) ago
Reference: 3201597994
Precision Medicine Group is seeking a Clinical Trial Manager to lead the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP and regulatory requirements. This role serves as the primary client contact and collaborates with PMs on budgeting, feasibility, and study documentation.
You will oversee site selection, enrollment plans, data quality, and CAPA development while coordinating with CRAs, QA, and vendors to deliver timely, compliant trial results.
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Remote Clinical Trial Manager - Oncology & Rare Diseases
Precision Medicine Group, LLC. View all jobs
Posted 8 day(s) ago
Reference: 3201597736
Precision for Medicine seeks a Clinical Trial Manager to lead the operational aspects of clinical studies across international sites. You will ensure adherence to protocols, SOPs, ICH-GCP, and regulatory requirements while serving as the primary point of contact for clients and study teams.
You will develop essential study documents, manage budgets, coordinate site feasibility, and train CRAs/vendor staff. This role requires strong communication, travel flexibility, and collaboration with
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Posted 8 day(s) ago
Reference: 3201596448
Location: Remote, Australia; Remote, Singapore; Remote, South Korea
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7304
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager.
Position Summary:
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project-specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Supports business development and marketing activities as appropriate
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- May manages workload of supervised staff with continued assessment and adjustment as needed
- Perform other duties as assigned by management
Minimum Required :
- Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
- Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
Other required:
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at so we can investigate and take appropriate action.
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy .
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
Apply Now
Already registered?
Sign in to pre-fill your personal details, attachments and more.
Success!
Your application has been submitted.
Email Shortlisted Jobs
Browse Job Locations
Email Sent Successfully!
Your shortlisted jobs have been sent to the recipient. They will receive the email shortly.
Email Failed!
There was an error sending the email. Please try again later.