Director, Data Management
1 day ago
Job Title: Director, Data Management
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
SummaryThe Director, Data Management is responsible for the oversight of data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the head of the Data Management group.
Responsibilities
- Direct and grow internal data management expertise area, including management of direct reports;
- Direct and establish standards for data management CRO outsourcing strategy and deliverables, including the CRO selection process and the governance of CRO performance;
- Oversee the successful execution of all data management activities in support of Alnylam clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving;
- Supervise the execution of cross-functional, internal data review plans by direct reports across all Alnylam clinical studies;
- Partner with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Global Patient Safety & Risk Management (GPSRM), Regulatory Affairs, and Medical Affairs; CROs, central and local laboratories, and other vendors;
- Lead development and implementation of data collection standards, consistent with industry best practice;
- Lead data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.
- Oversee development of department workflows, and infrastructure strategy and implementation, such as preferred provider initiatives, SOPs, and templates;
- Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards;
- Collaborate with Clinical Operations and Quality Assurance to certify the integrity and traceability of all clinical data sources, compliant with 21 CFR Part 11 standards;
- Direct Data Management GCP inspection readiness efforts; function as a leader for Data Management in GCP inspections;
- Represent Data Management at internal cross-functional meetings and external vendor leadership meetings;
- Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture and Passion for Excellence.
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 15 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company, with at least 5 years in a leadership capacity;
- Extensive experience managing global studies utilizing an outsourced CDM model from start-up through close-out;
- Extensive experience managing direct reports and providing performance reviews and career development guidance;
- 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 Medidata Rave EDC systems;
- Experience working with MS Office Suite (Excel, Word and PowerPoint) familiar 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.
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.
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/53d32868bfa35a4a9cfc068c5d9b0092
-
Associate Director, Data Management
1 day ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Senior Data Management Director
1 month ago
Cambridge, Massachusetts, United States Prometrika LLC Full timeJob OverviewPrometrika LLC is a leading clinical research organization with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for delivering high-quality results and our commitment to fostering a collaborative work environment.About the RoleWe're seeking an...
-
Associate Director
4 weeks ago
Cambridge, United States Pioneer Data Systems Full timePosition Details: Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Manager to join their expanding team. Job Title: Clinical Data Manager / Digital Health Technology Duration: 12 months contract, extendable up to 36 months Location: Cambridge, MA Note: The client has the right-to-hire...
-
Clinical Data Management Director
3 weeks ago
Cambridge, Massachusetts, United States Prometrika Full timeWe are seeking a Clinical Data Management Director to join our team at Prometrika. This is an exciting opportunity for a seasoned professional to lead and manage a team of clinical data managers, overseeing the entire project lifecycle from start to finish.About the RoleThis role will be responsible for managing and supervising a team of clinical data...
-
Senior Director, External Data Management
24 hours ago
Cambridge, United States Lifelancer Full timeJob DescriptionJob DescriptionJob Title: Senior Director, External Data ManagementJob Location: Cambridge, MA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: DirectorWhy Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD)...
-
Data Platform Director
2 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceuticals Full timeAbout the Role:Takeda Pharmaceuticals seeks a highly skilled Data Platform Director to oversee the development and implementation of AI-powered data platform initiatives. The ideal candidate will possess expertise in data management standard methodologies, including data ingestion, integration, security, warehousing, analytics, metadata management, and...
-
Director, Technical Program Management
5 months ago
Cambridge, United States Capital One Full timeCenter 3 (19075), United States of America, McLean, VirginiaDirector, Technical Program Management - Enterprise DataAbout Capital One: At Capital One, we're changing banking for good. We were founded on the belief that no one should be locked out of the financial system. We're dedicated to helping foster a world where everyone has an equal opportunity to...
-
Data Management Leadership Position
2 weeks ago
Cambridge, Massachusetts, United States Prometrika LLC Full timeAt Prometrika LLC, we are seeking a highly skilled Associate Director to join our team in the Data Management department.About UsPrometrika is a full-service clinical research organization with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. Our mission is to drive innovation and bring...
-
Director of Commercial Data Strategy
2 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeAbout the RoleWe are seeking an experienced Director of Commercial Data Strategy to join our team at Alnylam Pharmaceuticals. In this critical role, you will be responsible for developing and executing a comprehensive data strategy that aligns with our commercial business objectives.ResponsibilitiesDevelop and execute Alnylam's commercial data strategy,...
-
Data Management Specialist
3 weeks ago
Cambridge, Massachusetts, United States Harvard University Full timeJob Overview:Data management is crucial for researchers at Harvard University. As a Research Data Management Consultant, you will be responsible for assisting researchers in managing, organizing, and sharing data throughout the research lifecycle. This role serves as a subject matter expert, providing consultation and instructional services to labs on data...
-
Data Insights Director
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeTransforming Commercial Success with Data-Driven LeadershipBiogen is seeking an accomplished Data Insights Director to lead our commercial strategy and drive business growth.About Biogen:We are a global biotechnology company committed to excellence and innovation. With a strong focus on patient-centricity, we strive to deliver life-changing medicines that...
-
Data Management Leadership Role
1 month ago
Cambridge, Massachusetts, United States Prometrika LLC Full timeJob OverviewPrometrika LLC, a leading clinical research organization (CRO), is seeking an experienced professional for the role of Associate Director, Data Management. This position will play a crucial part in the company's mission to deliver high-quality data management services to its clients.
-
Data Management Strategist
2 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeAbout the Role:We are seeking a highly skilled Director of Data Management to lead our commercial data strategy and drive business outcomes.Responsibilities:Develop and execute a comprehensive commercial data strategy that aligns with our business objectives.Leverage data analytics and insights to inform business decisions and drive revenue...
-
Data Management Strategist
3 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeJob DescriptionThis role is a rare opportunity to join Alnylam as a seasoned data management professional and take on the challenge of driving commercial data strategy, architecture, and governance.As Director of Commercial Insights, you will be responsible for leading cross-functional teams to develop and implement cutting-edge data solutions that drive...
-
Senior Director, Technical Program Management
2 months ago
Cambridge, United States Capital One Full timeCenter 3 (19075), United States of America, McLean, VirginiaSenior Director, Technical Program Management (Enterprise Data and Machine Learning)About Capital One: At Capital One, we're changing banking for good. We were founded on the belief that no one should be locked out of the financial system. We're dedicated to helping foster a world where everyone has...
-
Director, Data Management
6 days ago
Cambridge, MA, United States Alnylam Pharmaceuticals Full time< This role is considered Hybrid.Overview The Director of Data Management will be responsible for overseeing and advancing Alnylam's Commercial data management strategy, data architecture, and implementation of data governance controls and policies. This person will work closely with business executives, stakeholders, and data stewards to identify,...
-
Global Clinical Data Management Director
2 weeks ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout the Role:We are seeking a seasoned clinical data management leader to oversee and lead all activities associated with the collection, transfer, and quality of clinical trial data collected from external sources.This individual reports to the Head of Clinical Data Management and is accountable for all Data Management timelines and quality of external...
-
Global Clinical Data Management Director
1 week ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout Sarepta TherapeuticsSarepta is at the forefront of genetic medicine, leading positions in Duchenne muscular dystrophy and limb-girdle muscular dystrophies. With over 40 programs in various stages of development, we are poised to revolutionize patient care.We seek solution-oriented critical thinkers who thrive in a dynamic environment. If you excel in...
-
Manager, Data Management
1 month ago
Cambridge, United States Prometrika Full timePROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market....
-
Data Director
1 month ago
Cambridge, Massachusetts, United States Vesalius Therapeutics Full timeAbout Vesalius TherapeuticsVesalius Therapeutics is a pioneering company that is revolutionizing the field of medicine by developing a platform to generate breakthrough treatments for common diseases. Our platform combines large-scale human genetics, genomics, stem cell studies, and artificial intelligence to uncover causal biology and identify optimal...
