Associate Director, Clinical Data Management

Beeline Medicines; Boston (MA); Hybrid; USD 181,000 - 235,000; Full time

Benefits offered by this job

Healthcare coverage

Paid time off

Long‑term incentive eligibility

Job summary

Beeline Medicines in Boston, MA, is hiring an Associate Director, Clinical Data Management to lead data management across clinical programs, oversee CROs, design databases, and ensure audit‑ready data for regulatory submissions.

The role partners with Biostatistics, Clinical Operations, and Quality, emphasizing CDISC standards, EDC systems, and data quality metrics to support timely milestones.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or related discipline, or equivalent education and experience.
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Experience in immunology or autoimmune therapeutic areas preferred
• Proven experience managing CDM activities across all phases of clinical development (Phase I–III), including late‑stage and/or registration‑enabling trials.
• Prior experience managing CRO relationships and overseeing outsourced CDM activities
• Proficiency with EDC platforms (e.g., Medidata Rave, Veeva Vault EDC) and CDISC (CDASH/SDTM/ADaM) standards.
• Working knowledge of data cleaning, query management, and database lock processes.
• Proficiency in medical coding dictionaries (MedDRA, WHO Drug) and coding conventions.
• Familiarity with centralized data review methodologies such as data visualizations and review tools for identifying data quality trends and leveraging RBM approaches.
• Ability to lead cross‑functional study teams and manage CRO performance without direct reporting authority.
• Strong written and verbal communication for cross‑functional and vendor collaboration.
• Ability to present data management status and risks to program leadership.
• Skilled at translating technical data issues into clear, actionable summaries for non‑DM stakeholders.
• Effective at facilitating technical system design discussions and data quality oversight review meetings with internal and external cross‑functional team members

Responsibilities

• Oversee the development and review of key data management study documents such as Data Management Plans, CRF/eCRF design specifications, data validation plans, custom listings/reports, and data cleaning plans.
• Oversee EDC and other clinical data systems build in support of protocol objectives, site‑level and patient‑level data entry workflows, user acceptance testing (UAT), database releases, mid‑study updates, interim snapshots and database lock activities.
• Monitor clinical data quality, study metrics and KPIs to ensure timely and accurate data cleaning, discrepancy management, medical coding (MedDRA, WHO Drug), and reconciliation of external data sources (e.g., central labs, eCOA, safety data).
• Contribute to internal and external cross‑functional study team meetings by communicating study status, proactively identifying risks to timelines, data quality, and regulatory compliance, and recommending mitigation strategies.
• Ensure all data management activities comply with ICH E6(R3) GCP guidelines, 21 CFR Parts 11 and 312, data security, privacy (e.g., GDPR, HIPAA) and other applicable global regulatory requirements.
• Contribute to process improvement initiatives, SOP development, and data management standards across programs.
• Strong understanding of CDISC standards CDASH/SDTM, statistical analysis dataset specifications, and submission‑ready data packages.
• Support preparation for regulatory inspections and audits by maintaining complete documentation of data management activities and sponsor oversight and ensure regular documentation filings into the Trial Master File.
• Perform other duties and responsibilities as assigned

Skills

Cross-functional leadership

Vendor management

CDISC standards

EDC platforms

Medical coding

Data cleaning

Query management

Regulatory readiness

Documentation

Communication skills

Presentation to leadership

System design facilitation

Education

Bachelor’s degree in Life Sciences or related field

Tools

Medidata Rave

Veeva Vault EDC

Job description

Associate Director, Clinical Data Management

About Beeline Medicines:

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact. Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

Job Summary:

The Associate Director, Clinical Data Management Leads clinical data management activities across one or more clinical programs, ensuring the timely delivery of high‑quality, audit‑ready clinical trial data in support of regulatory submissions and clinical development timelines. Acts as the primary data management point of contact for assigned programs, overseeing CRO and vendor performance, database design, and data cleaning strategy from study start‑up through database lock. Partners closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Pharmacovigilance and Quality to ensure data management deliverables align with study milestones, data quality objectives and inspection‑readiness standards. This role combines deep technical data management expertise with the leadership skills needed to guide cross‑functional teams and external vendors toward consistent, high‑quality outcomes. This role reports to the Director, Clinical Data Management.

Work Arrangement & Location:

Hybrid – This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week – currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Oversee the development and review of key data management study documents such as Data Management Plans, CRF/eCRF design specifications, data validation plans, custom listings/reports, and data cleaning plans.
• Oversee EDC and other clinical data systems build in support of protocol objectives, site‑level and patient‑level data entry workflows, user acceptance testing (UAT), database releases, mid‑study updates, interim snapshots and database lock activities.
• Monitor clinical data quality, study metrics and KPIs to ensure timely and accurate data cleaning, discrepancy management, medical coding (MedDRA, WHO Drug), and reconciliation of external data sources (e.g., central labs, eCOA, safety data).
• Contribute to internal and external cross‑functional study team meetings by communicating study status, proactively identifying risks to timelines, data quality, and regulatory compliance, and recommending mitigation strategies.
• Ensure all data management activities comply with ICH E6(R3) GCP guidelines, 21 CFR Parts 11 and 312, data security, privacy (e.g., GDPR, HIPAA) and other applicable global regulatory requirements.
• Contribute to process improvement initiatives, SOP development, and data management standards across programs.
• Strong understanding of CDISC standards CDASH/SDTM, statistical analysis dataset specifications, and submission‑ready data packages.
• Support preparation for regulatory inspections and audits by maintaining complete documentation of data management activities and sponsor oversight and ensure regular documentation filings into the Trial Master File.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education:Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline, or equivalent education and experience.
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Experience in immunology or autoimmune therapeutic areas preferred
• Proven experience managing CDM activities across all phases of clinical development (Phase I–III), including late‑stage and/or registration‑enabling trials.
• Prior experience managing CRO relationships and overseeing outsourced CDM activities
• Proficiency with EDC platforms (e.g., Medidata Rave, Veeva Vault EDC) and CDISC (CDASH/SDTM/ADaM) standards.
• Working knowledge of data cleaning, query management, and database lock processes.
• Proficiency in medical coding dictionaries (MedDRA, WHO Drug) and coding conventions.
• Familiarity with centralized data review methodologies such as data visualizations and review tools for identifying data quality trends and leveraging risk‑based monitoring (RBM) approaches.
• Ability to lead cross‑functional study teams and manage CRO performance without direct reporting authority.
• Strong written and verbal communication for cross‑functional and vendor collaboration.
• Ability to present data management status and risks to program leadership.
• Skilled at translating technical data issues into clear, actionable summaries for non‑DM stakeholders.
• Effective at facilitating technical system design discussions and data quality oversight review meetings with internal and external cross‑functional team members

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by applicable local law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$181,000 - $235,000 USD

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.