Associate Director, Clinical Data Management

Summary of Key Responsibilities

• Operate as program level Data Management lead in support of multiple Alnylam clinical studies in an outsourced model by providing strategic support, coordination, and oversight of key Data Management deliverables and activities such as eCRF development and user acceptance testing, review of CRO data management documentation, data cleaning and coding review (including oversight and execution of internal Data Review Plan), SDTM dataset development, and database lock;
• Manage team of direct reports, providing oversight of individual study lead work activities along with strategic advice, career development guidance and mentorship; establish performance goals for each direct report and provide regular performance review feedback; develop and execute onboarding plan for training of new hires;
• Serve as an active member of the Data Management leadership team, supporting growth of the expertise area via ownership of and/or participation in standards and process development initiatives & projects, such as authoring SOPs, work instructions, documentation templates and data collection standards consistent with industry best practices;
• Support Director with aspects of Data Management CRO outsourcing strategy and partnership development, including request for proposal development, selection process, partnership management, key performance indicator and budget oversight, process improvement initiatives and the day-to-day oversight of CRO deliverables;
• Support Director with internal resource planning and other strategic planning initiatives and objectives;

• Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards;
• Collaborate with internal stakeholders to certify the integrity and traceability of all clinical data sources, including CRF and non-CRF data, compliant with 21 CFR Part 11 standards and with the appropriate supporting documentation of the data flow;
• Collaborate with Clinical Operations on Risk-Based Quality Management activities, including supporting cross-functional study team and Clinical Risk Manager in protocol risk assessment, risk identification and evaluation, and set-up and maintenance of RBQM system; participate in development and expansion of clinical data risk analyst team;

• Support GCP and pre-approval inspection readiness by functioning as a lead for Data Management for all associated preparatory activities (including strategic planning, documentation assembly and mock inspections); participate in the live GCP and pre-approval inspections as a subject matter expert for Data Management;
• Represent Data Management at internal cross-functional team meetings and external vendor meetings, effectively assessing and communicating risks, requirements, and timeline expectations
• Demonstrate clear alignment withAlnylam Core Valuesincluding Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence

Qualifications

• BS/BA with least 12 years of related industry data management experience in a biotechnology / pharmaceutical company; including at least 3 years of management experience;
• Extensive CRO/vendor management experience in an outsourced data management model;
• Extensive experience managing direct reports and providing performance review feedback and career development guidance;
• Experience leading data management process improvement initiatives and/or standards development;
• Experience working as a data management lead in clinical drug development through Phase 3, managing multiple, global studies in an outsourced model from study start-up through close-out; experience with rare disease and cardiac therapeutic area studies preferred;
• Experience working with Medidata RAVE EDC system;
• Experience using standardized medical terminology, including MedDRA and WHODrug;
• Knowledge and understanding of CDISC SDTM data standards and direct experience with Pinnacle21 validation process;
• NDA, BLA, MAA and/or J-NDA submission experience as a data management lead preferred;
• Direct experience participating in FDA, EMA and/or PMDA pre-approval inspection(s) preferred;
• Expert knowledge and understanding of industry regulations and best practices, including ICH GCP & 21 CFR Part 11 requirements and CDASH standards for data collection;
• Excellent written and oral communications skills with extensive experience presenting to a senior management audience;
• Experience working with MS Office Suite (Excel, Word, PowerPoint) and familiarity with MS Project;
• Highly motivated and flexible, with excellent organizational and project management skills;
• Ability to work independently and as part of a multi-disciplinary team

U.S. Pay Range

$161,800.00 - $218,800.00

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.