Senior Manager/Associate Director, Data Management

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

The Senior Manager/Associate Director, Data Management will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. The Senior Manager/Associate Director, Data Management will be responsible for executing Data Management (DM) activities and deliverables across multiple studies. You would be independently leading key data management activities including vendor management, Case Report Form (CRF) design, clinical database development, creation of data management plans and study-related documents, reviewing and executing data transfer agreements and CRF completion guidelines, implementation of programmed edit checks and data quality listings, clean patient tracking, and database closure. This position will report to the Director of Clinical Development and will be the primary individual responsible for data review.. 

RESPONSIBILITIES: 

• Will act as the DM Study Lead across multiple studies 
• Represent DM in cross-functional meetings 
• Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival 
• Establish and maintain strategic business relationships with DM-related vendors; apply effective vendor management throughout the study 
• Responsible for ensuring complete and accurate documentation such as CRF specifications, CRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans 
• Oversee thorough development testing of the CRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and any other applicable testing 
• Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources 
• Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements 
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells 
• Act as the primary reviewer of data and discrepancy management for all data review activities, including reviewing data in EDC, raising queries, working with study monitors and site staff to address data issues.  
• Participate in reviews of tables, figures, and listings (TFL) and patient profiles output prior to generate templates and for final database locks 
• Report query trends and data/query/SDV metrics to the Study Execution Team (SET) 
• Participate in the development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed 
• Prioritize projects and coordinate data management activities in support of corporate goals and objectives 
• Ensure DM project documentation is in an inspection-ready state 
• May provide line management for DM supporting roles 
• May lead initiatives focused on DM process improvement, data quality assurance and efficiency

QUALIFICATIONS:

• 8+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus 
• Experience running Ph I-IV clinical trials, through CRO partners (rare disease and retrospective study experience is a plus)
• Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
• Understanding of Good Clinical Data Management Practices
• Proficiency in CDISC standards (CDASH, SDTM, ADaM) 
• Experience with SAS, SQL and/or other clinical programming tools 
• Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP 
• Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, external vendor management, DM study documentation and inspection readiness. 
• Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems 
• Strong interpersonal, organizational, and communication (oral and written) skills 
• Exceptional organizational, time management, and communication skills
• Demonstrated ability to cultivate strong working relationships with internal and external colleagues. 
• Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities 
• Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude 
• Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues. 
• Willing to travel if required

The salary range for this position is $165,000 - $200,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.