Job description

Clinical Project Manager

Conshohocken, Pennsylvania, United States

CLINICAL PROJECT MANAGER

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

The Clinical Project Manager (CPM) will be responsible for overall management and oversight of contracted clinical studies and/or programs, including (but not limited to) development of project documentation, training project staff, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables. They will work to ensure that all aspects of the conduct of the study and/or program are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. The CPM will be asked to participate in the company's process improvement initiatives. Additionally, they could mentor study support staff (e.g. Clinical Trial Managers, Clinical Trial Associates) and may have direct reports (e.g. Clinical Trial Managers) across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.

Responsibilities:

  • Responsible for the successful execution and oversight of assigned programs ensuring the deliverables are met with quality, timelines and budget.
  • Provide oversight and accountability of all third-party vendors assigned to a program.
  • Support RFP processes from proposal development through to vendor selection and contract negotiation.
  • Review, negotiate and approve any required change orders.
  • Management of the overall study budget, ensuring the budget stays within forecast and the approved budget.
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP's and maintaining awareness of GCP guidelines.
  • Ensure program meets all GCP/ICH Guidelines and is Inspection Ready.
  • Contribute to authorship of company protocol and amendment development as required.
  • Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection.
  • Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals.
  • Input into regulatory documents such as 1B and DSUR.
  • Manage supportive Clinical Operations function(s) (e.g., Clinical Trial Managers), by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate.
  • Accountable for ensuring all study deliverables and milestones are met with quality and within timelines.
  • Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets.
  • Provide support/escalation point for direct reports as needed.

Qualifications: 

Essential

  • Experience with Vendor oversight..
  • Fully understand and apply the principles of GCP, ICH, GDP and relevant CFRs is required.
  • Create and maintain healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required.
  • Ability to communicate and coordinate activities with the internal team, clinical sites and vendors.
  • Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision.
  • Ability to work independently.
  • Experience presenting high level presentations, both orally and in writing using organizational skills to complement this.
  • Ensure an enthusiastic and open attitude towards continuous professional development.

Desirable

  • Proven ability to manage multiple protocols.
  • Familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus.
  • Experience with all aspects of the conduct of a clinical study including start-up through close out.
  • Knowledge of and experience with immunotherapies and/or Oncology therapeutic discipline.
  • BA/ BS. or higher in science related field (biological science, pharmacy or other health related discipline).
  • At least 4 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority oftime in clinical study/project management.
    • Experience must include global/international studies or
    • Experience in oncology is highly.
    • Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant lmmunocore IRT and EDC systems and programs.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.  

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

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