Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management is responsible for program level oversight of clinical data management activities in support of Alnylam studies via both strategic and hands-on support, management of direct reports, oversight of vendors, and contributions to departmental process and standards development, including Risk-Based Quality Management (RBQM). This position reports to the 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 with Alnylam Core Values including 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
• If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.