Clinical Operations Program Manager
Proclinical is currently recruiting for a Clinical Operations Program Manager for a global pharmaceutical company. Successful candidate will be responsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards on schedule and on budget.
- Accountable for planning and operational strategy for assigned clinical trials.
- Provide subject matter expertise and operational input into protocol synopsis and final protocol document.
- Challenge study team to ensure operational feasibility, inclusive of patient and site burden.
- Validate budget and ensure impacts are adequately addressed.
- Participate in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
- Challenge study team to ensure timelines meet the needs of the clinical development plan.
- Provide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
- Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
- Review and approve key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring.
- Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study level
- Study team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutes
Skills and Requirements:
- BA/BS or international equivalent required; Life Sciences preferred.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English.
- Experience must include Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area is advantageous.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.