|Title:||Director, Clinical Operations|
|Department:||Research and Development|
You will be responsible for the planning, implementation, execution and management of clinical research studies. In addition, you will manage clinical outsourcing to CROs and other vendors such as IXRS, labs, IRBs, etc. We are looking for candidates with the ability to author, review and approve various study related documents; evaluate issues, interpret data, suggest and implement solutions. Responsible for the financial and budgetary planning and tracking of assigned studies.
- Represents and leads the study team to design (as appropriate), develop and deliver the clinical study to agreed upon timelines.
- Ability to integrate and summarize medical/scientific concepts in protocols and other documents.
- Collaborates with project physician and statistician on clinical trial designs.
- Ability to author synopses, protocols, ICFs, sections of Investigator Brochures; reviews and approves study related plans.
- Develops and executes complex study plans in one or more clinical study(ies).
- Responsible for the clinical review and approval of Case Report Forms and provides clinical input into corresponding completion guidelines.
- Responsible for identification and selection of investigator sites.
- Responsible for planning and conducting investigator’s meetings. Presents information at the investigator meeting.
- Provides input and coordinates the on-schedule delivery of clinical trial supplies in collaboration with Clinical Supply representative.
- Collaborates with Clinical Supply representative on the selection and management of IXRS vendor.
- Leads team through selection process and provides input into contracts, change orders, and/or work orders.
- Requests and critically evaluates proposals and change orders from CROs and vendors.
- Develops and monitors budget for assigned study(ies).
- Contributes to negotiating budgets and contracts with CROs, vendors and/or investigative sites (as applicable).
- Trains and manages CRO / other clinical vendor activities to ensure the quality consistent with company and regulatory requirements.
- Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
- Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
- Manages escalation of study related isses and communicates as appropriate with management and other R&D functions.
- Ability to anticipate potential study issues and prepare contingency plans with minimal oversight.
- Responsible reviewing monitoring reports relating to the study.
Evaluates CRO and vendor performance for future work.
Must have a Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required with at least 8 years of clinical research experience with evidence of increasing responsibility within a pharmaceutical company, CRO or similar organization, experience leading cross functional teams, and detailed knowledge of current regulatory requirements and guidelines governing clinical research.