Sr. Clinical Program Manager
Proclinical is currently recruiting for a Senior Clinical Program Manager with a global pharmaceutical company located in Redwood City, CA. Success candidate will join the Data and Statistical Sciences (DSS) team and be responsible for coaching and mentoring team members.
- Aligns study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team.
- For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level.
- Interacts with and influences cross-functional team members to achieve program objectives.
- Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits.
- Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance.
- Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives.
- Conducts study execution "lessons learned" across functions.
- May include indirect supervision of employee as well as supervision of work of contract resources.
Skills and Requirements:
- Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's preferred. PMP Certification or Lean Six Sigma Green Belt desired.
- Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
- In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred.
- Demonstrated performance as a functional leader.
- Demonstrated ability to influence others without direct authority.
- Demonstrated ability to successfully coach / mentor in a matrix environment.
- Demonstrated effective communication skills.
- Demonstrated effective analytical skills.
- Experience with EDC and Data Management.
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 Catherine Nguyen at (+1) 215-531-5643 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.