Sr. Clinical Trial Manager
The Senior Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials.
• Develops and coordinates clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget.
• Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management). May participate in project core team meetings. Provides regular and timely input to the assigned Project Manager
• Reviews and contributes to protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs). Develops informed consent documents.
• Coordinates the qualification and selection of investigative sites, plans for and presents at Investigator Meetings, develops other site training materials
• Develops clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
• Partners with the CSP in identifying appropriate vendors for possible selection. Participates in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection.
• Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget.
• Responsible for ensuring the development and updating of cost estimates at the study and project level.
• Partners with the Clinical Services Partnership (CSP) team in developing complete clinical trial external cost estimates (sites and vendors) and maintains responsibility for the management of the clinical trial budget
• Ensures CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits, and initiates/follows up/tracks significant or relevant project issues at investigative sites
• Ensures study execution compliance with GCP/ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits
• Develops trial monitoring plans and tracks and reports compliance
• Partners with the Clinical Trial Associate I/II to ensure the TMF is developed, maintained, and archived
• Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards
• Actively communicates project issues and identifies emerging risks, then works with internal governance team of director-level (and above) multidisciplinary drug development professionals to help resolve project challenges
Education required/ preferred: Bachelor's degree required. BSN/RN, or Bachelor's Degree in a science background preferred.
Experience: • Minimum of 5 years of directly related experience required; clinical research experience strongly preferred.
• Previous monitoring, study coordination, data management and/or clinical project management experience including vendor/CRO management is required.
• Experience with opioid analgesics late stage trials a plus.
Previous phase 2-3 experience preferred, and osteoarthritis experience highly desirable.
• Knowledge of cGCP, ICH and FDA regulatory requirements.
• Solid project management, analytical and problem solving skills.
• Travel as needed to resolve field issues, provide training, and meet with partners and CROs.
BioStaff Solutions is a minority, female owned clinical resourcing firm providing clinical talent to the Pharmaceutical, Biotechnology and Medical Device industry. Our founding partners have a combined 60 years of strategic recruitment experience, with a total of 26 years in clinical staffing. We thrive in supporting environments where curiosity and expertise lead to discovery and innovation.
BioStaff Solutions offers a diverse range of recruitment services including: contract, contract to hire and direct placements in SAS Programming, Clinical Programming, Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Monitoring and Regulatory Affairs.
Wed, 19 Apr 2017 09:21:51 PDT