Project Manager

2 months ago

Philadelphia, United States Coalition of Cancer Cooperative Groups Full time
Job DescriptionJob Description

The incumbent will be responsible for assisting in the daily oversight, training, and resource allocation of the Data Management Staff, working on new initiatives and related projects ensuring that all tasks and projects are completed in a timely and efficient manner, and interacting with other Coalition functional areas and industry collaborators to support the various needs of the department and company.

Preference will be given to candidates who can work a hybrid schedule with 1-2 days/wk in our Center City Philadelphia office, but remote candidates with experience will be strongly considered.

Responsibilities:

  • Responsible for assisting in the management and daily oversight of data management staff.
  • Development of data management and regulatory use related SOP and work instructions.
  • Mentors and trains data management staff.
  • Serves as a liaison to industry sponsors when collaborating on data management related deliverables.
  • Serves as a liaison to Medidata Rave for Rave-related initiatives.
  • Assists with study building and liaises with study builders to ensure communication flow when updates to forms are needed on a study specific and global level.
  • Develops and/or reviews standard library of CRFs, edit checks, and custom functions.
  • Serves as SME for CDASH/CDISC compliance as well as contained SDTM mapping
  • Assists with and oversees implementation of each clinical study database into production.
  • Oversees projects and assignment of projects as necessary.
  • Assists the Senior Director by providing input into improving processes and implementation of new procedures.
  • Oversees the maintenance of all Data Management department SOPs. Authors related SOPs, WI, and other documentation and tools to enhance the functioning of the Data Management department.
  • Serves as the primary contact for the Data Management department, when the Senior Director is unavailable.
  • Participates in all required meetings and conference calls, including industry collaborations.
  • Reviews contracts and scopes of work for Industry collaborations.
  • Liaises with Senior Director, Clinical Research and industry collaborators to successfully deliver negotiated data management contract deliverables.
  • Develops and presents data management presentations.
  • Assists with the department’s hiring process.
  • Assess relevant training needs for staff in consultation with Senior Director, including assessment methods and productivity metrics. Also includes any relevant study build topics such as validations, migrations, etc.
  • Works with leadership and Project Managers to assess and identify training needs across the office.
  • Participates in the performance review of junior staff.
  • Manages multiple priorities, assesses needs and adjusts workloads accordingly.
  • Provides effective feedback in a sensitive and diplomatic manner.
  • Maintains an objective and neutral perspective when evaluating the work of fellow coworkers.
  • Assumes responsibility for multiple special projects, as assigned by the Senior Director, Clinical Research

Desired Experience

  • A minimum of five (5) years of experience in data management for clinical research trials (oncology).
  • Data management experience in a pharmaceutical company or CRO.
  • Experience in oncology clinical research.
  • Thorough understanding of data collection and management practices related to oncology-specific clinical trials.
  • Strong Medidata Rave experience.
  • Understanding and familiarity with regulatory use related to data management (including global data management experience) preferred.

Education

  • A bachelor’s degree from an accredited institution of higher education or equivalent work and/or relevant professional experience is required.
  • Medidata certifications for data management.
Company DescriptionThe Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.

The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.Company DescriptionThe Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.\r
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The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.

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