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Associate Director, Clinical Program Management

Cambridge, MA 02142

Posted: 11/14/2019 Employment Type: Direct Hire Job Category: Clinical: R&D Program Management Job Number: 2470

Job Description

Our client is looking to add an Associate Director, Clinical Program Management to its team on a permanent basis. The person in this role will plan, initiate and execute clinical studies (one or more large, complex, global) and implement appropriate standards and processes to ensure clinical study quality as well as be responsible for clinical study(ies) budget(s). Primary responsibilities will be managing and leading the day-to-day operations of the assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements across the globe.

  • Responsible and accountable for one or more concurrent clinical studies
  • Develops and manages trial budget & MS Project timeline
  • Leverages resources, expertise and knowledge across projects
  • Manages the direction, planning and execution of the clinical trials including RFP process and vendor selection
  • Maintains oversight of the CRO and is responsible for the quality of CRO work through regular review and evaluation of work product throughout the duration of the trial
  • Identifies and reports potential issues effectively and in a timely manner and implements corrective action.
  • Develops status reports and participates in the dissemination of clinical information to internal stakeholders
  • Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
  • Reviews critical study documents created by CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools etc.
  • Participates in protocol development and review of CSR
  • Coordinate and lead cross functional teams as needed
  • Works with clinical supplies on study drug quantities and packaging requirements
  • Contribute in the review of data management related activities
  • Participates in reviewing and approving investigational sites based on complete site assessment by CRO
  • Participates in contracts and budgets negotiations with clinical sites and vendors and facilitates review with legal department
  • Participates in the coordination of investigator meetings and all other study management meetings
  • Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
  • Mentors indirect reports, trains team members, including vendors, as needed
  • Review and contribute to the development of departmental SOPs
  • Must be able to travel as needed

Requirements / Qualifications:
  • MS/MA Degree in science or health-related field plus 5-8 years’ clinical research experience of which 3 years must be direct study management experience in the pharmaceutical industry.

  • BA/BS Degree in science or health-related field plus 7-10 years’ clinical research experience of which 5 years must be direct study management experience in the pharmaceutical industry.
  • Thorough understanding of clinical trial methodology, GCP/ICH and drug development process
  • Good verbal and written communication skills, works effectively/congenially in a team setting
  • Excellent interpersonal and organizational skills and ability to deal with competing priorities
  • Detail oriented with strong problem solving and decision making skills
  • Ability to work on teams and with multiple projects, and works well under general direction
  • Excellent computer skills
  • Ability to provide appropriate leadership to clinical sites
  • Independently motivated, capable of changing direction quickly if needed
  • Must be able to travel up to 20%, domestically and internationally

Meet Your Recruiter

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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