Associate Director, Clinical Data Management jobs in United States
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Relay Therapeutics · 1 month ago

Associate Director, Clinical Data Management

Relay Therapeutics is a clinical-stage precision medicines company focused on transforming the drug discovery process. The Associate Director, Clinical Data Management will oversee data management activities for clinical programs, ensuring the integrity, quality, and compliance of clinical data while collaborating with cross-functional teams and managing CROs and vendors.

BiotechnologyHealth CareTherapeutics
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

You will be responsible for oversight and execution of data management activities for assigned clinical programs including data timelines and key deliverables
You will work directly with and oversee CROs and vendors for outsourced Data Management activities. Is responsible for CRO performance and data management metrics for assigned programs
You will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals
You will lead data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP)
You will be responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs
You will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables
You will ensure compliance with global regulatory requirements and quality standards
You will contribute to data standards including CRF and participate in data system development initiatives and database integration projects
You will participate in SOP development, training of junior data managers, process mapping, and other departmental activities

Qualification

Clinical Data ManagementOncology ExperienceRegulatory ComplianceCRO OversightData ValidationCommunication SkillsInterpersonal SkillsOrganizational SkillsProblem-Solving Skills

Required

7+ years of experience in the pharmaceutical / biotechnology industry as a Data Manager
Advanced experience with data collection and cleaning covering Phase I, II and III studies
Experience in executing clinical studies across various phases is desirable
Strong and current knowledge in global regulatory and compliance requirements including but not limited to US CFR, EU CTD, ICH GCP, and CDISC
Experience in CRO and vendor oversight
Motivated self-starter who is 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 a high degree of attention to detail
Pragmatic and able to manage multiple projects and needs effectively

Preferred

Sponsor experience is strongly preferred
Oncology experience is preferred
Expertise in oncology drug development is preferred

Company

Relay Therapeutics

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Relay therapeutics is a developer of an allosteric drug-discovery platform intended to apply computational techniques to protein motion.

H1B Sponsorship

Relay Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (2)
2022 (5)
2021 (6)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$1.4B
Key Investors
Nextech InvestSoftBank Vision FundBiotechnology Value Fund
2024-09-10Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $30M
2022-09-12Post Ipo Equity· $300M

Leadership Team

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Sanjiv Patel
President and CEO
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Imogen Pryce
Chief Operating Officer, R&D
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Company data provided by crunchbase