Job Title: Clinical Study Manager Job Description The incumbent will be responsible for ensuring the delivery and execution of clinical studies in one or more geographic regions in the West, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget, and objectives set forth by the Study team. This role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.
Responsibilities - Develop project cross-functional, integrated study plans to study start-up (in-house) and validate and manage the overall study plan provided by the CRO.
- Participate in site selection and site qualification with the study team and CRO.
- Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments.
- Take responsibility for meeting logistics, agendas, and minutes of the clinical study team in accordance with standards.
- Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross-functional integration and delivery of items per the study plan.
- Oversee the CRO and provide timely input to ensure that CRO-generated documents are created in a timely manner ahead of study start.
- Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.
- Work closely and oversee CRO activities for study execution on a task/operational level per the project plan.
- Oversee CRF completion and monitoring; triage, resolve or escalate study issues to the supervisor.
- Oversee CRO study close-out and support database lock and review of TLG before and after database lock.
- Ensure internal tracking systems are updated.
- Manage CRO performance to ensure adherence to scope of work within timelines and budget at a task level.
- Track short-term operational study timelines and monitor operational performance metrics throughout the study.
- Identify issues and propose solutions; proactively assess potential risks to the study and propose mitigation plans.
- Monitor study budget against progress and bring deviations to the supervisor.
- Review and approve Vendor invoices, including investigator grants and pass-through costs.
- Provide oversight of the CRO to ensure compliance with quality measures.
- Contribute to the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP.
- Conduct quality oversight monitoring visits as outlined in the QOP.
- Review and document CRO-generated reports such as trip reports, protocol deviation reports, and analysis of site metric reports.
- Identify areas of concern and either resolve or bring to the attention of the Delivery Lead.
- Coordinate and liaise on audit activities.
- Provide oversight of the transmittal of trial and site-level documents to the Document Control Center (DCC) in support of the Trial Master File (TMF).
- Reconcile the CRO-generated TMF document trackers with the document archive and resolve issues with the reconciliation.
Essential Skills - 4 or more years of trial management experience at a biotech or pharma company.
- Hematology experience.
- Global trial management experience.
- Experience with Phase II/III trials.
- BS degree in life sciences or a related field.
Additional Skills & Qualifications - Experience with clinical or basic research in a pharmaceutical company, medical device/diagnostic company, Academic Research Organization (ARO), or Contract Research Organization (CRO).
- CRA experience is preferred.
- Time spent directly in a medical environment (e.g., as a Study Site Coordinator) is also considered relevant.
- Master's degree (MS/MPH), PharmD, or PhD is preferred.
- Support the department in codifying existing knowledge and best practices.
- Prepare training in the area of expertise and make recommendations for areas of improvement and innovation.
- Educate the team on adherence to SOPs, GCPs, and on best application of operational tools.
- Work with the supervisor to provide input into individual career development plans.
Work Environment The work environment involves coordinating with multiple internal and external stakeholders, including CROs and various vendors. The role requires a high level of organization and attention to detail to ensure compliance with all regulatory guidelines and company standards. This position is highly collaborative, often involving cross-functional teams to achieve study objectives.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ...@actalentservices.com for other accommodation options.