Clinical Project Manager

The Opportunity:

As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integral member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients.

The Role:

• Contribute to the planning, implementation, and execution of a global clinical trial(s) from startup through closeout. Lead and manage integration of the project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Collaborate and partner with a dynamic Relay cross-functional team to deliver clinical studies that are on time and within budget guidelines, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
• Provide leadership and input into global patient recruitment plans including the documentation of assumptions.
• Develop and maintain strong working relationships with internal and external stakeholders (cross-functional team members, Contract Research Organizations (CROs), external experts, and clinical site staff), ensuring high-quality services are executed in a timely and cost-effective manner.
• Manage reports for communicating study progress and key metrics to Senior Management and program teams.
• Contribute to or author key study documents including, but not limited to, protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee), study plans and clinical study reports.
• Accountable for effective vendor management by:
  • serving as primary point of contact for contracted CROs and vendors
  • identifying potential risks and proactively resolving issues with CROs and vendors
  • ensuring vendor contracts meet requirements and are efficiently executed with key performance indicators
  • partnering with the vendor to ensure accurate budgeting and accrual of costs throughout duration of each clinical study
• Ensure reliable quality data is delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
• Develops and drives granular clinical study timelines and enrollment projections and contributes to the development of Key Performance Metrics and risk mitigation strategies.
• Monitor and manage vendor and site performance, trial progress and quality through evaluation of defined study performance metrics.
• Proactively identify risks and issues, and work with the trial team to assess impact, devise strategies to implement corrective actions or preventive measures to mitigate risk.
• Develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
• Lead coordination with CROs on site selection, IRB/EC submissions and queries, site initiation and close-out planning.
• Provide oversight and ensure maintenance of clinical trial master files (TMF) to ensure compliance with required regulatory and ICH GCP quality standards and consistency with SOPs.
• Plan, execute and lead study-specific meetings (internal study team meetings, vendor meetings, Investigator Meetings, etc.), as needed.
• Support the preparation of regulatory filings (e.g. IND, NDA, orphan drug applications etc.) as needed.
• Ensure inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.
• Obtains and maintains an in-depth understanding of the study protocol and related procedures to contribute strongly to Study Team knowledge by sharing best practices, making recommendations for continuous improvement, and training/mentoring as appropriate.
• Fosters an environment of continuous improvement and actively participants in the recruitment, training and professional development of clinical operations team members

Your Background:

• Minimum of 5-8 years of experience in clinical research with 1-2 years managing trials in the biotech/pharma industry. BA/BS preferably in a scientific or health-related discipline.
• Experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies and a strong working knowledge of GCP/ICH and other applicable regulations/guidelines required. Strong preference for tenured experience in the biotech/pharmaceutical industry in late phase clinical trials.
• Solid experience and understanding of the challenges of navigating global study startup including the oversight of site startup processes and timelines.
• Experience across several complex therapeutic areas. Oncology experience is a plus.
• Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
• Understand clinical study budgets, accruals, and forecasting with experience liaising with Finance as required.
• Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.
• Enjoy building relationships with CROs, KOLs and site personnel with a willingness to travel to establish and build relationships.
• Experience in vendor selection and overseeing studies managed by a CRO.
• Strong interpersonal and relationship-building skills; ability to influence and collaborate across functions and levels.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
• Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality).
• Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage timelines and budget.
• Detail-oriented, a self-starter and comfortable with broad responsibilities in an fast-paced, small company outsourced trial environment.

Estimated Salary Range: [$102,000 - $145,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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