Associate Director, Clinical Data Management
Why Work for Us?
Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care
We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development an commercialization of next-generation bispecific and multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
About the Position
Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.
This position will report to the Director, Clinical Data Management and will be based in Seattle, WA.
- Oversee and direct clinical data management (CDM) activities across multiple studies and compounds
- Provide oversight, guidance, mentoring, feedback and performance reviews
- Lead and oversee hiring and training activities as needed
- Manage work performed by vendors/CROs to ensure quality product and timelines, objectives and deliverables are met
- Represent Zymeworks CDM on cross-functional project teams
- Help select and manage the performance of CROs and other outside vendors
- Participate in the development/review of all CDM documentation including but not limited to eCRFs, CRF Completion Guidelines, Data Management Plans, Edit Checks, Data Review Plans, Data Transfer Specifications, etc.
- Develop and guide team members through the implementation of SOPs, templates and processes and other departmental and/or cross functional projects
- Direct data cleaning activities such as study team data reviews, SAE reconciliation, non-CRF data reconciliation, non-system edit checks
- Provide direction and guidance to team members, including consultants and vendors to achieve/meet corporate goals and milestones
- Oversees the tracking of important study metrics on data entry, source data verification, query status, data trends and presents these metrics to a cross-functional team as required
- Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with management and cross-functional teams
- Guide team on non-CRF data expectation, data reconciliation and cleaning activities on clinical studies, including on pivotal, blinded, and randomized trials
- Drive and guide complex departmental initiatives and new technologies/innovations to improve processes and infrastructure
- Align with and support management and corporate objectives
- Communicate and message information to multiple levels of leadership appropriately; applying appropriate level of detail to audience to ensure efficient utilization of resource
- Lead collaborations through relationship building with other leaders
Qualifications and Experience
- BA/BS in life sciences or relevant field, with at least 10 years of relevant industry experience. An equivalent combination of education and experience may be considered.
- At least 4 years management experience
- Thorough knowledge/understanding of the principles of clinical research, ICH, GCP, GCDMP, and CDISC standards
- Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities
- Experience working with and managing external service providers/vendors
- Cross collaboration proficiency with other functional areas with ability to work effectively in a team setting, as well as independently
- Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and projects seamlessly with excellent attention to detail
- Flexible with excellent problem-solving and negotiation skills
- Relevant therapeutic experience in oncology and inflammatory disease desired
- Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion
- Lead and develop team of clinical professionals.
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.