Senior Manager, Clinical Data Management

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 145,000 - 196,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off and holidays

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead data management activities across studies. The role reports to the Director/Associate Director and involves cross-functional collaboration with Biostatistics, Clinical Operations, Regulatory Affairs and CROs.

Responsibilities include program-level data management leadership, database build oversight, vendor management, regulatory submissions support, and staff coaching. Strong GCP/CDISC experience required.

Qualifications

• BSc/BA in scientific discipline, MS preferred.
• At least 10 years related experience in a pharmaceutical/biologics/biotechnology company.
• Experience managing global studies through Phase 3 in outsourced CRO model; rare disease experience preferred.
• Experience managing direct reports and providing performance reviews.
• Experience developing Data Management SOPs and standards.
• Understanding of ICH GCP and regulatory requirements for clinical data systems; CDISC standards familiarity.

Responsibilities

• Function as program level data management lead in support of Alnylam clinical studies, as individual contributor and manager of direct reports.
• Lead oversight of database build activities, including cross-functional review of eCRF content and UAT.
• Monitor data collection, cleaning and coding by CROs; oversee study database lock activities.
• Participate in drafting/timelines and ensure deliverables and milestones are met.
• Provide strategic guidance to reports and cross-functional teams on data management for database locks and regulatory submissions.
• Train, mentor and oversee direct reports; conduct performance reviews.

Education

BSc/BA in scientific discipline, MS preferred

Tools

Medidata Rave

MS Office Suite

MS Project

Job description

Senior Manager, Clinical Data Management

The Senior Manager, Clinical 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, Clinical Data Management or Associate Director, Clinical Data Management.

Summary of Key Responsibilities

• Function as program level data management lead in support of Alnylam clinical studies, operating both as an individual contributor and manager of direct reports;
• Lead oversight of database build activities, including cross-functional review of eCRF content, review of edit check specifications, and performance of user acceptance testing
• Monitor data collection, cleaning and coding by CROs via the execution of internal data review plans and review of all vendor data management documentation; provide oversight of all study database lock activities;
• Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met;
• Provide strategic guidance to direct reports and internal cross-functional team members regarding data management activities in support of database locks, regulatory submissions and/or other key study deliverables
• Train, mentor and oversee work activities of direct reports; provide regular performance review assessments
• Author and contribute to development and implementation of departmental standards and infrastructure strategy, such as SOPs, data collection standards and document templates, consistent with industry best practices;
• Support GCP inspection readiness and participate as subject matter expert in GCP inspections;
• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors;
• Collaborate effectively 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 laboratories, and other vendors;
• Review clinical protocols/amendments, clinical study reports, etc.;
• Demonstrate clear alignment with Alnylam Core Values including Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Qualifications

• BS/BA in scientific discipline, MS or equivalent preferred
• At least 10 years related experience in a pharmaceutical/biologics/biotechnology company;
• Extensive experience managing global studies through Phase 3 in an outsourced CRO model from start-up through close-out; experience with drug development in rare genetic diseases preferred;
• Experience managing direct reports and providing performance reviews and career development guidance;
• Experience developing Data Management SOPs and standards;
• 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;
• Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management Systems;
• Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH;
• Experience using standardized medical terminology, including MedDRA and WHODrug;
• Experience working with Medidata Rave EDC system;
• Experience working with MS Office Suite (Excel, Word and PowerPoint), familiarity with MS Project;
• Excellent written and oral communication skills;
• Highly motivated and flexible, with excellent organizational skills;
• Ability to work independently and as part of a multi-disciplinary team
• NDA/MAA submission experience preferred;

#LI-AB1 #LI-Virtual

U.S. Pay Range

$144,500.00 - $195,500.00

The pay range 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).

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

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

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.