Clinical Project Manager at Relay Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

5+ years of experience in clinical study management (sponsor experience strongly preferred)
Recognized as a clinical operations expert with a track record of success in study execution, accelerating timelines, maintaining data integrity, and satisfying health authority requirements
Experience executing clinical studies across various phases (desirable); expertise in oncology drug development preferred
Strong and current knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP applicable to clinical trials
Experience in CRO, vendor, and laboratory oversight
Motivated self-starter capable of flourishing in a fast-paced small company environment
Creative problem-solver with excellent communication and public speaking skills

Responsibilities

Oversee day-to-day operations of study execution, focusing on site oversight from startup to closeout, patient enrollment, monitoring, compliance, and data flow/metrics from sites, CROs, and vendors
Collaborate with cross-functional team to deliver studies on time, within budget, and in accordance with protocol and ICH GCP guidelines
Develop and maintain strong relationships with investigators, site staff, and vendors globally, explaining complex scientific topics
Manage reports communicating study progress and key metrics to Senior Management and program teams
Contribute to or author key study documents (e.g., protocols, informed consent forms, case report forms, governance charters, study plans, clinical study reports)
Manage vendors as primary point of contact, identify/resolve risks, ensure contracts meet requirements with KPIs, and partner on budgeting/cost accrual
Ensure quality data by reviewing monitoring reports, protocol deviations, data listings, and performing/overseeing site monitoring visits
Develop action plans for protocol compliance, safety, data, and administrative issues with sites and CROs
Coordinate with CROs on site selection, IRB/EC submissions, site initiation, and close-out planning
Provide oversight and maintain clinical trial master files (TMF) for compliance with regulatory, ICH GCP, and SOP standards
Partner with CRO to lead, plan, and execute Investigator meetings and study meetings
Participate in preparation of regulatory filings (e.g., IND, NDA, orphan drug applications)
Ensure inspection readiness by collaborating with CROs and supporting sites for audits/inspections
Assist with onboarding and mentoring new or junior clinical operations associates

Skills

Clinical Trial Management

CRO Management

Vendor Management

ICH GCP

Site Management

Protocol Development

Informed Consent Forms

Case Report Forms

Data Monitoring

Patient Enrollment

Budget Management

Regulatory Compliance

Relay Therapeutics

Biotech company focused on drug discovery

About Relay Therapeutics

Relay Therapeutics focuses on drug discovery by studying protein motion to develop new treatments for complex diseases. Their main tool, the Dynamo™ platform, uses both experimental and computational methods to identify potential drug candidates, especially for conditions that are hard to treat with current therapies. This platform allows them to target proteins that have previously been difficult to address, particularly in areas like precision oncology and genetic diseases. Unlike many competitors, Relay Therapeutics emphasizes the importance of protein dynamics in their research, which sets them apart in the biotech field. Their goal is to create effective medicines that can significantly improve patients' lives, and they are actively conducting clinical trials to ensure the safety and effectiveness of their drug candidates.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$535MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO

Risks

Increased competition from VantAI threatens Relay's market position.

Layoffs may impact Relay's operational efficiency and research progress.

Reliance on public offerings suggests potential financial instability for Relay.

Differentiation

Relay's Dynamo platform targets previously undruggable proteins, expanding treatment possibilities.

Focus on protein motion places Relay at the forefront of innovative drug discovery.

Relay's precision oncology approach tailors treatments to individual genetic profiles.

Upsides

AI-driven drug discovery complements Relay's computational techniques, enhancing drug development.

Quantum computing integration could boost Dynamo's capabilities in drug discovery.

Rising personalized medicine trend aligns with Relay's precision medicine focus.

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