New · posted Oct 31
Alnylam Pharmaceuticals · Biotechnology
Principal Clinical Data Manager
- Cambridge, MA
- On-site
- Full-time
- Senior & Principal
The role
The Principal Clinical Data Manager, Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the Director, Data Management or Associate Director, Data Management.
The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
What you need
- BS/BA in scientific discipline
- 7-9 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company
- Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
- Experience leading initiatives/projects for SOP, process and standards development within clinical data management
- Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation
- Experience working with Medidata Rave
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
- Excellent written and oral communications skills
- Highly motivated and flexible, with excellent organizational, time and project management skills
- Ability to work independently and as part of a multi-disciplinary team
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
- NDA/MAA experience
What you'll do
- Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies
- Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics, internal data reviews and vendor key performance indicators
- Oversight of database lock activities and ultimate archiving of study data
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members
- Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
- Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution
- Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
- Mentor and train internal colleagues on data management activities and tasks as needed, fostering a collaborative environment of learning, growth and development
- Participate in the training of external vendors and site staff
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
- Function as a leader for GCP inspection readiness activities for Data Management and serve as a primary point-of-contact for DM during inspections
- Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
Pay and benefits
$147,900 – $200,100 a year
Employer providedMedical, dental and vision coverage
Life and disability insurance
401(k) with company match
Paid time off and wellness days
Annual bonus and equity eligibility
Family resources and leave
Where you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
U.S. Pay Range
$147,900—$200,100 USD
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Clinical Data Management roles at this level.
This roleEmployer provided
Senior & Principal roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $147,900 | — | $200,100 |
| All US (middle half) | $132,500 | $148,000 | $159,500 |
This role: Alnylam Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 29 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership14
- Data and digital systems11
- Documentation and SOPs8
- Clinical trial conduct8
- GMP and compliance5
- Lab testing and methods2
- Validation and qualification2
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Alnylam on Regulatory Jobs
- 15
- Open roles
- 14
- Distinct roles
- 4
- Locations
By discipline
- Clinical8 53%
- Regulatory4 27%
- Quality3 20%
By level
- Director8 53%
- Manager3 20%
- Senior & Principal2 13%
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Principal Clinical Data Manager at Alnylam
Open until filled. $148K–$200K a year, employer provided.