Clinical Project Manager - Clinical Operations
Immunocore

Conshohocken, Pennsylvania

Posted in IT


Job Info


About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesThe 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 of time 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.



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