Clinical Trial Manager
Vacancy expired!
Clinical Trial ManagerSan Rafael, CaliforniaApplyType:ContractCategory:Scientific & ClinicalJob ID:155476Date Posted:08/28/2020Job Title: Clinical Trial ManagerNumber of Openings: 1Job Description:KEY RESPONSIBILITIES:I. Study Planning & Management
Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin SOPs, ICH and FDA and other Health Authorities (HAs))
Oversee study feasibility assessment activities (if applicable)
Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan
Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
Provide CLO study activity timeline and budget inputs to overall Study
Team timeline and budget
Lead cross-functional effort to define enrollment strategy and plan for the study
Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
Provide study status updates to the Study Team and Study Team Lead
Vendor Management
In collaboration with appropriate teams, oversee and approve vendor evaluation and selection
Oversee day-to-day management of CRO and vendors' contracted activities as per oversight plans
Work with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure 4. Study Conduct Startup:
Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants
Plan and deliver IM in collaboration with other key stakeholders 5. Enrollment and Maintenance:
Ensure adherence to study enrollment strategy and plan
Ensure adherence to monitoring plan
Ensure adherence to monitoring oversight SOP
Ensure timely site payments
Partner with Patient Advocacy to manage patient travel, housing and associated management of patient costs
Work closely with specialty vendors to ensure samples are being received and analyzed according to study team/protocol expectations 6. Closure:
Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
Coordinate and oversee data listing reviews
Ensure timely delivery of clinical documents for the CSR and appendices 7. Cross- Functional Representation
Act as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teams
Ensure CLO responsibilities for any cross-functional deliverables are met throughout the study, including study close-out and delivery of CLO related appendices for finalization of CSR
Oversee, train and mentor junior study team CRAs and CTAs on study.
Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality and budget.
Manage protocol deviation reviews in collaboration with CLS
Provide forecast for clinical supply, including ancillary supplies and comparator drugs
Contribute expertise to departmental and cross-functional process improvement activities
Oversee eTMF maintenance
Keep team driving to be in a state of constant Inspection Readiness
SkillsPrevious experience working in global environment History of successfully developing effective relationships with outside vendors and CROsOutstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical OperationsDemonstrated skills in negotiation, multi-tasking, organization and decision makingAbility to travel to global sites required.Prior experience working on cross-functional teams in a lead capacitySchedulePreference for candidates that are able to be office-based (post-pandemic) at San Rafael, CA campus, with some flexibility for work-from-home days as appropriate.Education:8 years of pharmaceutical industry experience6 years of experience in clinical researchApply
Vacancy expired!