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Clinical Trials Manager


  • Beacon Hill Staffing Group - Pharma
  • 10/05/19
  • Fort Lee, NJ
  • 07024
  • 65.00 / Hourly
  • Contractor
Clinical Trials/Study Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. In addition to exceptional project delivery, we seek strong analytical skills and leadership qualities that will influence our internal team and motivate our CRO partners. The ideal candidate values bringing important medicines to patients in need, and shares our teams determined, positive attitude.

Responsibilities:

Broad view of the departmental goals and sees the big picture scientifically and strategically.

Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status.

Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets, timelines, and external vendor(s) management.

Proficient in clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics.

Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials.

Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.

Ensures compliance of clinical trials with federal and applicable regulatory agency requirements.

Assists in the development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.

Integrates best practices as appropriate.



Qualifications:

BS/MS in a science or a health-related field.

4 - 6 years of related work experience, with at least 2 years in a study management role.

Biopharmaceutical (Sponsor) organization experience is a must. CRO experience is also desirable.

Demonstrated effectiveness in resolving study management issues.

Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required

In-depth knowledge of the CRO selection and contracting processes

Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization

Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance


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