Senior Clinical Project Manager (2 Openings)
Department: Regulatory Clinical
Reports to: Director of Clinical Affairs
The Senior Clinical Project Manager is responsible for the design, execution, and results of significant clinical studies. This includes building the project plan, developing the protocol, initiating and executing the clinical study, and working with Regulatory to use study results for product approvals. Studies must be conducted meeting enrollment timelines and budgets. The position ensures all studies are conducted in compliance with GCP and all applicable standards and regulations.
Strategic Focus Areas:
- Provide leadership and accountability to meet corporate clinical goals, including execution of clinical studies in accordance with the protocol; meeting study timelines and budgets.
- Ensure the design and conduct of the clinical studies is done in full compliance with GCP and regulatory standards.
- Ensure study results are thoroughly characterized, summarized appropriately and in a manner conducive to achieving regulatory approvals.
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including study investigators, vendors, and appropriate government and regulatory authorities.
Specific Tactical Responsibilities:
- Develop clinical protocols
- Prepare and present study project plan including timelines and budgets
- Identify potential vendors for the clinical trial execution, including CROs, Monitors, EDC data management systems, Imaging Core Labs, and Biostatisticians. Qualify and select vendors
- Direct site selection and qualification processes
- Negotiate site, investigator, and vendor contracts and budgets in collaboration with Finance Department
- Prepare all documentation associated with clinical studies to include case report forms, informed consent documents, investigator agreements, investigator brochures, case report form completion guidelines, logic checks and data handling guidelines and other required documents
- Plan, monitor and report patient enrollment and implement corrective actions as necessary to meet enrollment targets
- Coordinate the production, labeling and shipment of clinical supplies with Operations groups
- Provide operational oversight during trial period; complete site visits, report review, report preparation, payments to sites, compilation and completion of Trial Master File
- Ensure study is conducted in full compliance to GCP and regulatory requirements
- Monitor vendor activity to ensure study is being conducted according to protocol, timelines and budget
- Contact for cross-functional study team including sales and marketing personnel; provide accurate and timely study updates for internal Anika stakeholders
- Prepare internal files and investigative sites for regulatory inspections; participate in on-site regulatory audits
- Complete closeout activities to include final reports.
- Prepare Clinical Summary Reports and clinical portions of regulatory filings
- Maintain internal Quality System documents (SOPs, etc.) in compliance with appropriate US and EU regulations
Complexity associated with designing and executing clinical trials is high, and requires considerable exercise of judgment and excellent problem-solving skills. Job requires maintenance of up to date knowledge of all applicable clinical guidelines and international clinical regulation and regulatory guidance. Travel required (up to 25%, domestic and international).
Supervises activities of external Contract Research Organizations, vendors, and investigational sites
- Bachelor’s degree in the life sciences or health care field
- 6 – 8 years in direct clinical project management experience within the biopharmaceutical or medical device industry
- Demonstrated experience as a Project Manager on multi-center, FDA regulated IDE and/or IND studies
Desired Experience, Knowledge, and Skills:
- Master’s degree in the life sciences or related health care field preferred
- Knowledge of medical terminology, physiology and pathophysiology is required. Experience in Orthobiologics indications preferred.
- Experience working with CROs and outside vendors in monitoring trials
- Prior experience with EDC systems
- Excellent computer skills, specifically with Microsoft Office Suite is required
- Professional presentation, verbal and written communication skills are required
- Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced matrixed environment
We are an Equal Employment Opportunity Employer