Associate Director, Clinical Data Management at Relay Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

7+ years of experience in the pharmaceutical/biotechnology industry as a Data Manager (sponsor experience strongly preferred)
Advanced experience with data collection and cleaning covering Phase I, II, and III studies (oncology experience preferred)
Experience executing clinical studies across various phases (expertise in oncology drug development preferred)
Strong and current knowledge of global regulatory and compliance requirements (e.g., US CFR, EU CTD, ICH GCP, CDISC)
Experience in CRO and vendor oversight
Motivated self-starter capable of flourishing in a fast-paced small company environment
Creative problem-solver with excellent communication and public speaking skills
Strong interpersonal and organizational skills with high attention to detail
Pragmatic and able to manage multiple projects and needs effectively

Responsibilities

Oversight and execution of data management activities for assigned clinical programs, including data timelines and key deliverables
Work directly with and oversee CROs and vendors for outsourced data management activities; responsible for CRO performance and data management metrics
Lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines, and related operations manuals
Lead data validation specifications and programs (e.g., manual data review guidelines, computerized edit check programs, Data Management Plans)
Execute or oversee data cleaning activities through to database lock (e.g., generating/managing queries, data review listings, coding adverse events/concomitant medications, reconciling serious adverse events and central labs)
Collaborate with cross-functional team to ensure timeliness and quality of data deliverables
Ensure compliance with global regulatory requirements and quality standards
Contribute to data standards (including CRF), participate in data system development initiatives, and database integration projects
Participate in SOP development, training of junior data managers, process mapping, and other departmental activities

Skills

Key technologies and capabilities for this role

Clinical Data ManagementeCRF DesignDatabase DevelopmentUATData ValidationEdit ChecksData CleaningQuery ManagementCRO OversightData Review ListingsAdverse Event CodingSAE ReconciliationData Management PlansCDISC Standards

Questions & Answers

Common questions about this position

What experience level is required for this role?

Candidates should ideally have 7+ years of experience in the pharmaceutical/biotechnology industry as a Data Manager, with sponsor experience strongly preferred.

What key skills are needed for clinical data management in this position?

The role requires advanced experience with data collection and cleaning for Phase I, II, and III studies, expertise in oncology drug development preferred, strong knowledge of global regulatory requirements like ICH GCP and CDISC, and experience in CRO and vendor oversight.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What kind of work environment can I expect at Relay Therapeutics?

The role involves flourishing in a fast-paced small company environment as a motivated self-starter, collaborating with a dynamic cross-functional team.

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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