Description
Primary responsibilities include:- Act as primary liaison to CROs and vendors for assigned clinical study/programs, ensuring adherence to project scope, deliverables and timelines
- Facilitate study start up with CROs and clinical sites to complete clinical documents (i.e. ICF, source document worksheets, CRF specifications and development, clinical site agreements, and other study documentation)
- Organize and run study team meetings and teleconferences
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
- Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory data, data cleaning status for assigned clinical study/program
- May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits as required
- Monitor the maintenance of the clinical trial master files
- Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical programs
- Contribute to the writing and implementation of Standard Operating Procedures, standard forms and study-specific guidelines
Experience / Skills Requirements:
- BA/BS and/or nursing degree required
- At least 10 years of experience in the Biopharma industry in clinical operations with at least 5 years direct clinical trial management experience (CRO experience a plus)
- Must have experience managing complex Phase 1 and global Phase 3 clinical trials, preferably in inflammation or oncology
- Strong experience in CRO and vendor management to support global clinical trials
- Excellent knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management
- Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation.
- Understanding of data management, statistics and medical writing processes for clinical development