CenterWatch

1+ months

Data Monitoring Committee Project Manager

WIRB-Copernicus Group (WCG)
Bala Cynwyd, PA 19004

General Information

Location: Bala Cynwyd, PA

Organization: ACI Clinical

Job Type: Full Time

Description and Requirements

The Data Monitoring Committee (DMC) Project Manager, at our Bala Cynwyd, PA office location, will serve as the bridge between our clients, internal teams and partners in order to manage the operational execution of multiple expert committee and/or clinical trial projects.  The person hired into this role will be experienced in the data monitoring committee and/or project management space and will possess the following traits a positive attitude, a curious mindset, a passion to delight clients, excellent communication skills and the desire to understand and grow our business.

 

EDUCATION REQUIREMENTS:  

  • Bachelors degree in related field and/or 5 years related experience in a clinical project management environment (CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job. 

QUALIFICATIONS/EXPERIENCE:  

  • At least three (3) years experience in Project Management or related industry experience in pharmaceutical or medical device companies.
  • Experience directly working with Statistics in clinical trials is preferred
  • Knowledge of Drug and/or Device Study Development and/or DMC processes.
  • Strong organizational, communication (written and oral), and time management skills required.
  • Knowledge of FDA, ICH and GCP guidelines as they apply to clinical studies and clinical data management.
  • Experience in developing and managing a budget.

ESSENTIAL DUTIES/RESPONSIBILITIES: 

  • Provide proactive leadership as the primary project leader for any assigned DMC project.
  • Serve as primary liaison to Sponsor regarding assigned DMC projects and/or programs.
  • Coordinate DMC meetings and assist DMC Chairperson
  • Record and disseminate minutes of open and closed sessions of DMC meetings
  • Submit formal DMC recommendations to the Sponsor
  • Facilitate communication between DMC members and Sponsor
  • Facilitate communication between DMC members and unblinded statistician
  • Facilitate workflows and DMC deliverables with the ACI biometrics teams
  • Monitor study-specific safety concerns when required and report them to the DMC members
  • Assure that project tasks and deliverables are properly executed and tracked according to defined budgets and timelines.
  • Manage project-specific budgets and timelines, including identification of changes in scope and preparation of change order budgets.
  • Support proposal development by providing 1) protocol-specific sections to proposal text and 2) specification as needed for budget development.
  • Provide regular (at least monthly) status reports to upper management.
  • Coordinate project team meetings and record and disseminate minutes of meetings.
  • Compile and retain study file for Sponsor.
  • Lead and/or participate in departmental initiatives. 
ABOUT US: 

ACI Clinical, a member of the WCG Clinical family, is a specialty provider of clinical trial committees and clinical trial advisory services. ACI maintains deep involvement in several public-private thought leadership efforts to improve the quality and effectiveness of clinical trials by enhancing data integrity for regulators and the scientific community to drive efficiencies in clinical research and enable more informed decision-making.

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Posted: 2019-07-04 Expires: 2019-09-09

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Data Monitoring Committee Project Manager

WIRB-Copernicus Group (WCG)
Bala Cynwyd, PA 19004

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