Clinical Trial Manager

Company: Planet Pharma
Location: San Rafael
Posted on: October 8, 2020

Job Description:

KEY RESPONSIBILITIES:I. Study Planning & ManagementEnsure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including company 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 charterContribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and othersIdentify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation PlanIdentify, 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 charterProvide CLO study activity timeline and budget inputs to overall Study2. Team timeline and budgetLead cross-functional effort to define enrollment strategy and plan for the studyParticipate in strategic study planning meetings (such as DMC, advisory board, steering committee)Provide study status updates to the Study Team and Study Team Lead3. Vendor ManagementIn collaboration with appropriate teams, oversee and approve vendor evaluation and selectionOversee day-to-day management of CRO and vendors contracted activities as per oversight plansWork with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure4. 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 & GrantsPlan and deliver IM in collaboration with other key stakeholders5. Enrollment and Maintenance:Ensure adherence to study enrollment strategy and planEnsure adherence to monitoring planEnsure adherence to monitoring oversight SOPEnsure timely site paymentsPartner with Patient Advocacy to manage patient travel, housing and associated management of patient costsWork closely with specialty vendors to ensure samples are being received and analyzed according to study team/protocol expectations6. Closure:Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)Coordinate and oversee data listing reviewsEnsure timely delivery of clinical documents for the CSR and appendices7. Cross- Functional RepresentationAct as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teamsEnsure 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 CSROversee, 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 CLSProvide forecast for clinical supply, including ancillary supplies and comparator drugsContribute expertise to departmental and cross-functional process improvement activitiesOversee eTMF maintenanceKeep team driving to be in a state of constant Inspection ReadinessRequirements:8 years of pharmaceutical industry experience6 years of experience in clinical researchSkillsPrevious experience working in global environmentHistory 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 capacity

Keywords: Planet Pharma, San Rafael , Clinical Trial Manager, Other , San Rafael, California