Associate Director, Data Management

Zenas BioPharma•Waltham, MA

55d•$152,000 - $191,000•Hybrid

About The Position

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation! Position Summary: The Associate Director, Clinical Data Management will drive the entire life cycle of key Zenas Data suppliers, from identification, selection, and on-boarding to performance management. This is an important cross-functional leadership position supporting within the R&D organization. This individual will work with Zenas leaders on strategy development, cost management, and performance management of key data vendors to ensure that desired goods or services, quality, and performance meet business needs. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization, in a manner consistent with our principle of TRUE Innovation. This position reports to the Executive Director, Data Management.

Requirements

Bachelor's degree required within a scientific discipline, math, computer science or related field with working knowledge of clinical data management processes and procedures
Minimum 8 years of data management experience within biotech/biopharma preferably in fast paced biotech
Demonstrated experience directly managing/overseeing clinical data management activities with external vendors/CROs including development/monitoring of clinical data metrics.
Extensive knowledge and experience in development/reviewing/execution of clinical data management study plans such as electronic case report (eCRF) specifications, edit checks, data management plans, data transfer specifications, coding plans, and electronic trial master plans (eTMF)
Experience performing/leading teams to perform user acceptance testing
Extensive data cleaning/data dredging experience
Solid understanding of FDA/EU regulations and guidelines including GCP, ICH, CDASH, and CDISC as applicable to clinical data management
Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)
Exceptional interpersonal skills and problem-solving capabilities
Excellent oral and written communication skills
Flexible, collaborative, and results driven

Nice To Haves

Experience with a CRO organization is a plus

Responsibilities

Implement data management vision for clinical data management on studies assigned by overseeing all clinical data management activities
Manage the CRO/vendor for clinical data management activities on studies assigned including leading, overseeing, and approving CRO data management documentation (e.g., Case Report Form (CRF) specifications, CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications, Data Management Plans, external reconciliations) to assure processes meet the protocol requirements ensuring data integrity and regulatory compliance
Develop strong relationships to optimize collaborative cross-functional engagement internally and with vendors to align with company priorities, goals, and objectives
Build and maintaining CRF standards to achieve cost efficiencies with external vendors and time efficiencies with Zenas colleagues
Lead the cross-functional team in user acceptance testing of the clinical database to align with protocol and analysis needs for the collection and cleaning of data
Assist the Head of Data Management by providing data management expertise in the preparation of project specific request for proposals, reviewing vendor specifications/budgets, and discussing/recommending vendor selection
Write protocol specific oversight data review plans on studies assigned, facilitate the cross-functional oversight data review preparation and meetings including following all data issues to resolution
Effectively manage functional area on assigned studies (resources, activities, processes, and documentation)
Proactively identify potential data issues/risks plus recommend and implement solutions on assigned studies.
Collaborating with internal colleagues providing clinical data management expertise, leadership, and support to other functional leads to meet and maintain cross-functional excellence to meet company objectives.
Manage aspects of clinical data management activities, including vendor performance, internal metrics, quality assurance checks, and communication of study status within and outside the study team on assigned studies..
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents by regularly auditing the Data Management section of the TMF to ensure complete and current CRO filing to meet regulatory requirements on assigned studies.