Relay Therapeutics

Relay Therapeutics

Clinical Project Manager

Cambridge, MA

Sponsorship not specified$102k-$145kDetected 23 days ago
GCPProject ManagementForecastingBudgetingVendor ManagementClinical TrialsClinical ResearchResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingMentoring

About the role

  • Contribute to the planning, implementation, and execution of a global clinical trial(s) from startup through closeout.
  • Provide leadership and input into global patient recruitment plans including the documentation of assumptions.
  • 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.

Responsibilities

  • 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.
  • 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.
  • Manage reports for communicating study progress and key metrics to Senior Management and program teams.
  • 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.
  • 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.
  • Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.

Requirements

  • 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.
  • Minimum of 5-8 years of experience in clinical research with 1-2 years managing trials in the biotech/pharma industry.
  • 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.
  • Understand clinical study budgets, accruals, and forecasting with experience liaising with Finance as required.
  • Excellent oral and written communication, organizational and planning skills are required, with a proven ability to manage timelines and budget.

Nice to have

  • Experience across several complex therapeutic areas.
  • Oncology experience is a plus.

Compensation

  • 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.
  • About Relay Therapeutics
  • Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients.
  • Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets.
  • We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Benefits

  • BA/BS preferably in a scientific or health-related discipline.
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