Worldwide Clinical Trials is seeking a Senior Clinical Research Associate/Lead Clinical Research Associate to drive site management activities across a geographic region. You will coordinate site qualification, initiation, monitoring, and close-out per protocol and SOPs, ensuring high-quality deliverables and TMF readiness.

The role requires leading a team, collaborative partner interaction, and strong knowledge of ICH guidelines, FDA/EU directives, and global regulatory requirements.

Worldwide Clinical Trials is hiring a Clinical Trial Manager for APAC, remotely based in Australia. You will lead site management and monitoring across multiple studies from initiation through close-out, coordinating with project teams and sponsors to ensure quality and timelines.

The role requires 3+ years as CRA or 5+ years with a two-year degree, strong leadership, GCP/ICH knowledge, and proficiency with EDC/CTMS/eCRF/IxRS. English fluency is essential.

Clinical Trial Manager - APAC - OncoWe use cookies to improve your browsing experience and help us improve our websites. We have carefully selected third parties that use cookies to achieve purposes illustrated in the cookie policy. For more information. Read more about online privacy statement. By closing this banner or continuing to browse our website, you agree to our use of such cookies. Discover a world of difference at Worldwide. Clinical Trial Manager - APAC - OncoApply: Remote: Virtual Australia: Full time: Posted Today: JR103259Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials , we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. Make an Impact as a Clinical Trial Manager at Worldwide Play a pivotal role in delivering high-quality clinical research by leading site management activities across clinical studies from start-up through close-out. In this role, you'll guide and coordinate clinical monitoring teams, ensuring studies are executed efficiently, compliantly, and with a strong focus on quality and patient outcomes.

You'll serve as a key partner to project teams, sponsors, and clinical research sites, driving monitoring strategy, overseeing operational performance, and proactively managing risks. Your leadership will help ensure studies remain on track, data quality is maintained, and sites receive the support needed to successfully deliver study objectives.

Working across multiple stakeholders and geographic regions, you'll bring together clinical expertise, operational oversight, and team leadership to achieve timely and successful study delivery. Where You'll Work This is a REMOTE role open to candidates based in Australia. You will collaborate with global teams across multiple time zones.

Travel will be required as part of this role. A valid passport and driver's license are required. What You'll Do Lead and coordinate site management and monitoring activities across clinical studies from initiation through close-out. Partner with Project Management to establish monitoring strategies, operational targets, and study execution plans aligned with project goals. Provide leadership, guidance, and clinical expertise to Clinical Research Associates and site management team members throughout the study lifecycle. Serve as the primary site management representative for sponsors, investigators, study teams, audits, inspections, and key project meetings. Oversee monitoring quality, site performance, protocol compliance, and timely completion of monitoring deliverables. Drive patient recruitment efforts, monitor enrollment performance, and support site-level strategies to keep recruitment on target. Review study metrics, trends, and analytics to improve site performance, data quality, and operational effectiveness. Identify, escalate, and help resolve study risks and site issues while implementing proactive mitigation strategies. Ensure Trial Master File compliance, inspection readiness, and adherence to study protocols, SOPs, regulatory requirements, and quality standards.

What You'll Bring Bachelor's degree (or equivalent) in biological, physical, health, nursing, life sciences, or a related field, with relevant clinical research experience; alternatively, a two-year degree with extensive Senior Clinical Research Associate experience. Minimum three years of experience as a Senior Clinical Research Associate (or equivalent), or five years with a two-year degree, and at least six months of experience supporting or functioning as a Clinical Trial Manager, Lead CRA, or equivalent role. Strong leadership experience with the ability to guide, motivate, and support remote clinical teams. Extensive knowledge of clinical research processes, monitoring practices, Good Clinical Practice (GCP), ICH Guidelines, FDA and/or EU regulations, and local regulatory requirements. Experience developing and implementing monitoring strategies, overseeing site performance, and managing clinical operations deliverables. Proficiency with Microsoft Office and clinical systems including EDC, CTMS, eCRF, IVRS, and IxRS platforms. Excellent planning, organizational, presentation, communication, negotiation, problem-solving, and stakeholder management skills. Proficiency in English.<img src="https://www.jobg8.com/Tracking.aspx?xCbrFR1m7vkPZ1XO2%2bX%2fUEbgb2AlkKcXv" width="0" height="0" />

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. SUMMARY: Responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer.

_Tasks may include but are not limited to:_ Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes Provide leadership and direction to clinical site management team members from study start through to closure Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project specific Audits / Inspections Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP) Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP. Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed Review/finalize trip reports according to Worldwide SOPs and expectations May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed Proactively identify and mitigate risks May represent site management as primary contact on projects Conduct co-visits where required to ensure quality of site, the CRA work and study procedures. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Excellent interpersonal, oral and written communication skills in English Excellent planning and organizational skills with effective time management Excellent presentation skills Flexibility to change Ability to manage multiple and varied tasks with enthusiasm Ability to negotiate and influence with diplomacy in order to achieve results Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision Ability to lead and motivate a team remotely Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities Strong customer focus, ability to interact professionally within a sponsor contact Extensive understanding of clinical research principles and process Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements Experience in the study therapeutic indication/area Thorough understanding of standard operating procedures Proficient knowledge of Microsoft Office, eCRF, IVRS packages Proficiency with IxRS, CTMS and EDC systems

Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, OR Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities Travel required Valid current passport required Driving license required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. Note the Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA)

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. We're a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we're here, you'll get a different answer. And that's what makes us special.

Worldwide Clinical Trials is seeking a Senior Clinical Research professional to lead site management activities and coordinate a team across a geographic region. You will ensure site qualification, initiation, monitoring, and close-out in alignment with study plans and SOPs.

The role requires strong leadership, regulatory knowledge, and cross-functional collaboration to deliver high-quality data and patient safety. A background in GMP/ICH and TMF management is essential.

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials , we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. SUMMARY: Responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer. RESPONSIBILITIES: _Tasks may include but are not limited to:_ Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes Provide leadership and direction to clinical site management team members from study start through to closure Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project specific Audits / Inspections Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP) Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP. Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed Review/finalize trip reports according to Worldwide SOPs and expectations May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed Proactively identify and mitigate risks May represent site management as primary contact on projects Conduct co-visits where required to ensure quality of site, the CRA work and study procedures. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. OTHER SKILLS AND ABILITIES: Excellent interpersonal, oral and written communication skills in English Excellent planning and organizational skills with effective time management Excellent presentation skills Flexibility to change Ability to manage multiple and varied tasks with enthusiasm Ability to negotiate and influence with diplomacy in order to achieve results Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision Ability to lead and motivate a team remotely Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities Strong customer focus, ability to interact professionally within a sponsor contact Extensive understanding of clinical research principles and process Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements Experience in the study therapeutic indication/area Thorough understanding of standard operating procedures Proficient knowledge of Microsoft Office, eCRF, IVRS packages Proficiency with IxRS, CTMS and EDC systems REQUIREMENTS: Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, OR Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities Travel required Valid current passport required Driving license required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. Note the Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA) Discover the DifferenceWe love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit , or connect with us on LinkedIn .<img src="https://www.jobg8.com/Tracking.aspx?

CH0%2fCe97HEaNyO70XL53Nm9t96PFfzuMt" width="0" height="0" />

Worldwide Clinical Trials in Australia seeks a Senior Clinical Research Associate to lead site qualification, initiation and interim monitoring visits, and manage study close-out activities in line with GCP and SOPs.

You will ensure data quality, timely safety reporting, and mentor less experienced CRAs and site staff. Strong knowledge of FDA/EU guidelines and IxRS/EDC tools is required for this senior role.

Senior Clinical Research Associate - Australia - CVM/IMIDApply: Remote: Virtual Australia: Full time: Posted Today: JR102960 Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!\ SUMMARY: Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. RESPONSIBILITIES:\ \_Tasks may include but are not limited to:\_Perform feasibility studies for potential sites as requestedConduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirementsFunction in the role of Lead CRA for global studies, coordinating CRAsDevelop Clinical Monitoring Plan as requestedConduct site visit trip report review and provide feedback and editsProvide mentoring and guidance to less experienced CRAs and site staff when neededDesign study specific tools and templates as requestedActively participate in study team and investigator meetingsActively participate in bid defensesCreate and conduct training to study team members or colleagues as requested and appropriateWork with Project Management to evaluate deliverables and study milestonesCompile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study siteDocument site visit findings via written reportsProvide input into the design of protocols and CRFs as requestedAssess, monitor, and train study site staff on protocol adherence as requiredReview study subject safety information and informed consentConduct source document verification for compliance, patient safety, and veracity of dataReview CRFs using paper or electronic data capture systems and assist sites with data query resolutionAssist the site in maintenance of the Investigator Site FileMaintain regular communication with sitesProvide applicable updates for site related documentation for filing in the Trial Master File (TMF)Ensure site compliance with IP receipt, accountability and return or destructionConduct accompanied site visits for assessment or training of other CRAs as requested and appropriateComplete final site close out visit and reportPerform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.\ OTHER SKILLS AND ABILITIES: \ Excellent oral and written communication skillsExcellent planning and organizational skills with effective time managementExcellent interpersonal skillsDemonstrate initiative and problem solving skillsAbility to lead and motivate assigned team (if applicable)Ability to provide experience and input into process initiatives and development relating to monitoring and site management activitiesExtensive understanding of clinical research principles and processThorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirementsThorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriateThorough understanding of standard operating proceduresProficiency in Microsoft OfficeProficiency with IxRS, EDC systems\ REQUIREMENTS:\ Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc. ) and with a minimum experience of three years as a Clinical Research Associate ORA minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of five years as a Clinical Research Associate, ORTwo-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum seven years as a Clinical Research AssociateWillingness to travel requiredValid current passport requiredDriving license requiredFluent in the local languages of the countries under responsibilities and proficient in both spoken and written EnglishPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.<img src="https://www.jobg8.com/Tracking.aspx?enmgxQvR3d1QOObzxsqJKBCuQvnsFyYUw" width="0" height="0" />

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Worldwide Clinical Trials Project management is the perfect blend of operational rigor and therapeutic expertise, with a client focused approach. Our Global Project Leads (GPLs) and Clinical Project Managers (CPMs) expertly guide our project teams to deliver with high quality, focusing on "doing it right the first time". The Project Management team is engaged in all aspects of the trial collaborating with scientific and therapeutic leadership, coordinating across project teams, and providing flexible, innovative and proactive solutions. At Worldwide, you will be dedicated to a specific therapeutic area which will not only give you an opportunity to develop in depth global operational expertise, but also benefit from exceptional scientific and medical background that our experts bring.

Project Manager (PM) is responsible for the overall coordination and management of clinical trials from start up through closeout activities.

• Directs the technical, financial and operational aspects of the projects thus securing the successful completion of clinical trials.
• Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented.
• Works to ensure that all project deliverables meet the customer's time/quality/cost expectations.
• The PM, with support from the Project Management Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations.

• Ability to manage projects in a multi office environment.
• Excellent interpersonal, oral, and written communication skills in English.
• Superior planning and organizational skills with attention to details.
• Proficiency in Microsoft Office, CTMS and EDC Systems.

• 5 years' industry experience with previous experience in a Clinical Project Management role, within a CRO setting.
• University/College degree, within Life Science is preferred.
• Experience managing Oncology studies is required for this role.
• Ability to travel when needed.

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

This is who we are.

We're a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we're here, you'll get a different answer. And that's what makes us special.

Worldwide Clinical Trials in Australia seeks a seasoned Project Manager to lead clinical trials from start-up to closeout. You will coordinate cross-functional teams, manage timelines, budgets, and quality to deliver high-quality results.

You should have at least 5 years of CRO experience, a Life Science degree, and oncology study experience, with ability to travel. Join a global team of experts committed to improving lives.