Director, Clinical Operations (Sr. Project Manager)

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Director, Clinical Operations (Sr. Project Manager)

 

Summary:

 

Lead the daily operations of the assigned clinical programs and associated deliverables, with a thorough understanding of the operational and strategic aspects of the project.  Functions as the clinical liaison with internal team members and vendors.

 

Main Responsibilities

1.            Create and implement project plans and guidance documents including protocol, clinical monitoring plan, data abstraction guidelines, study reference manual, training   
              material.

2.            Organize and provide program training for the study team.

3.            Oversee all aspects of the clinical operations of the study including site identification, study start up, activation, and enrollment.

4.            Participate in operations activities as needed (e.g. conducting SIVs, performing site management tasks, data monitoring).

5.            Manage and lead the project team.

6.            Manage the generation and delivery of a quarterly status report.

7.            Review invoices for accuracy and ensuring they are appropriate to pay.

8.            Perform other duties as assigned.

 

Qualifications

 

Education & Experience Bachelor's degree, preferably in medical or biological sciences or discipline associated with clinical research. 4 years of related pharmaceutical or biopharmaceutical industry experience, with at least 2 of those years in a clinical operations lead or manager role.

License or Certification  None. 

 

Knowledge, Skills, & Abilities      

 

Excellent interpersonal and communication skills, both written and oral. Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word). Strong organizational skills. Ability to work independently as part of a cross-functional team with minimal direction. Ability to be a high achiever with strong track record of delivering. Ability to problem solve in non-traditional ways. Demonstrated ability of initiative, teamwork and accountability. Ability for a strong attention to detail and accuracy. A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines. Ability to follow guidelines and procedural documents.

 

To apply, please send a cover letter and resume to [email protected] and indicate the job title in the Subject line.