@Orchard | A Leading Provider of Technical Workforce Solutions

Project Manager - Pharmaceutical Drug Development

Job Title
Project Manager - Pharmaceutical Drug Development
Job ID
27366669
Location
Princeton,  NJ 08540
Other Location
Description

Project Manager - Pharmaceutical/Biotechnology

ClinicalTrial Protocol Management

Princeton, New Jersey

Talent Orchard LLC has been retained by a fast-growing biopharmaceutical firm, with a direct focus on Oncology research and development, to assist in building an exceptional team of experienced professionals. Currently, we have an opportunity to satisfy a new Project Manager need, located at their Princeton, NJ Headquarters. This is an exceptional opportunity for an experienced Project Manager to really have an impact on managing every aspect in coordinating the project management lifecycle for products in Phases I-IV of clinical development. This is a new role being created within our client's organization with the potential for exceptional career growth. From competitive compensation to fully funded healthcare and 401 matches, our client is committed to supporting the great people of their team with an exceptional environment, while their product pipeline is very exciting, pointing to longevity and security.

Our client is a wholly-owned subsidiary of a global pharmaceutical powerhouse and works urgently to discover and develop innovative cancer treatments. As cancer evolves, our client evolves with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower them to redefine the way the world treats cancer.   

The Project Management (PM) works exclusively at the protocol level and is responsible for leading one or more Clinical Trial Teams and coordinating all aspects of team activities for assigned studies from protocol synopsis through final CSR. This individual, in concert with team members from Clinical Development, Clinical Operations, Project Management, Regulatory Affairs, Biostats, Data Management, Biomarkers, Clinical Supplies, Pharmacovigilance and Medical Writing, is accountable for achieving successful delivery of assigned clinical studies on time and on budget. 

Responsibilities

  • Project Manage every aspect of the deliverable from project planning and implementation strategy, through to the executables, operational plan (scope, critical paths, roles & responsibilities), through to oversight of budget and risk identification/mitigation.
  • Work cross-functionally with internal and external stakeholders to ensure alignment to the plan, resource allocation and be responsible for assigning budgetary and resource effort to meet specific project priorities.
  • Be responsible for the total team's compliance with the project plan and in meeting budget and deliverable targets.
  • Seek to identify opportunities throughout the project to accelerate deliverables without compromising on quality or regulatory requirements and adjusting the project plan accordingly.
  • Utilize Microsoft Project (MS Project) and ultimately Planisware to own the coordination of deliverables, timelines and milestones across functions all aligned to delivering a successful clinical trial.
  • Detailed tasks include;
    • Coordinate the activities of all the functional representatives on the team to ensure the seamless execution of clinical study protocols. 
      • Activities include but are not limited to: protocol and case report form development, vendor selection and vendor management, site selection and activation, clinical supplies, data management, biostatistics analysis plans, generation of interim and final analyses, clinical study reports, publications and the generation and maintenance of the electronic Trial Master File.
    • Work with team members to develop detailed integrated project plans for each protocol and ensure these are folded into the overall project plan to meet the company’s product development objectives. (MS Project, Planisware)
    • Provide protocol specific regularly scheduled updates on trial status to functional area management and to senior management within TOI and TPC when requested.
    • At the overall project level, work proactively to ensure that Protocol Team priorities are aligned with: global project plans prepared by Project Planning and Management, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
    • Ensure significant protocol specific issues and potential study risks are escalated to the attention of the PDT and relevant functions, when appropriate.
    • Co-chair all protocol related vendor meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
  • Other duties as assigned

Qualifications

  • Three to five years of project management experience. PMP Certification strongly preferred.
  • Demonstrated, expert-level capabilities utilizing MS Project to track all activities essential to the execution of multiple complex drug development initiatives.
  • Prior experience with Planisware preferred
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
  • Experience in Clinical Operations or as a Study Coordinator in Pharma, Biotech, Device or CRO industry. 
  • Experienced study coordinators from Oncology academic centers with demonstrable Project Management and MS Project capabilities will also be considered 
  • Therapeutic experience in oncology (preferred). 
  • Minimum of a Bachelor’s level degree, with a preference for Life Sciences, Nursing, or Pharmacy.
  • Experience in early all phases of clinical trials (Phase I-IV) (preferred)

Established in 2010, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.  Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.talentorchard.com.

Option 1: Create a New Profile