CLINICAL RESEARCH MANAGER - REDWOOD CITY, CA

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

 LOCATION: REDWOOD CITY -   CA

Primary Job Function

· Overall management of a single study (s) of less complexity and limited geographic scope.
· Ensure activities that impact a study(s) are performed according to the development plan for the study(s)

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

· Leader of a study team
· Contribute to the Development of the Study Plan which includes key milestones, timelines cost and resources, Monitoring, Communication, IP, Recruitment & Retention Plans.
· May provide limited input to clinical regulatory documents (e.g., Investigator’s Brochure (IB), CSR, CSS, CSE, CO, and the IND Update).
· May author Protocol and related study documents with input from Therapeutic Area, and other key stakeholders. 
· Support country selection at study level and drive site selection.
· May oversee and manage vendors (e.g., CROs, laboratories, etc.). May assist with identification and selection of vendors
· Provide overall study status updates/progress reports to study team members
· Manage an approved study budget of up to $30MM.
· Contribute to the development of and testing of the specifications of systems (e.g., EDC, IRT, ePRO, etc.)
· Ensure all systems (e.g. CTMS, CT.gov) reflect current study status.
· May Plan and coordinate internal and external meetings (e.g., Investigator Meetings and monitor meetings)
· Responsible for some content development and delivery of internal and external study-related  training
· Ensure effective study communications to internal and external stakeholders through meetings, presentations and other methods.  (i.e., Study Team). 
· Communicates regularly with extended study team including Regional Managers to review country/site status, issues, study timelines and ongoing data quality.
• Ensure  development , quality consistency and compliance of clinical study (s)
• Evaluate study-level issues and execute action plan to ensure resolution.
• Actively identifies and escalates quality and compliance concerns.
• Ensures audit / inspection readiness at site level.  Contributes to audit/ inspection responses as part of cross-functional clinical study team.

Position Accountability / Scope

· Set study strategy by ensuring alignment with program strategy.
·  Will primarily support one program.
Responsible for problem solving, risk mitigation and contingency plans at study level with oversight

Minimum Education

Bachelor’s degree or equivalent is required, typically in nursing or scientific field.  Advanced degree is desirable.

Minimum Experience / Training Required
 
· Must have 6+ years of direct clinical research experience
· Experience in multiple phases (e.g., I, II, III) and multiple  stages (e.g., startup, maintenance, close out) of clinical operations desirable
· Monitoring and/or  site/ study management experience desired
· Experience in a regulatory environment desirable.
Demonstrated competence in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing)