The Associate Director, Data Management leads all aspects of clinical data management, ensuring quality and compliance across programs while managing vendors.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
The Associate Director, Data Management is responsible for providing leadership and expertise in all aspects of clinical data management for an assigned program(s) or study(ies). This person will contribute via both strategic and hands-on support, oversight of vendors, and contributions to departmental process and standards development.
Position Responsibilities:
- Excellent written and oral communications skills with extensive experience presenting to a senior management audience;
- Experience with Oncology and/or Autoimmune therapeutic areas;
- Extensive CRO/vendor management experience in an outsourced data management model;
- Highly motivated and flexible, with excellent organizational and project management skills;
- Ability to solve complex, abstract problems in cross-functional collaboration and independent projects while demonstrating pro-active efforts, sound decision-making, and attention to detail;
- Experience working with EDC systems (Ex: RAVE, Veeva EDC, etc.);
- Knowledge of CDASH, MedDRA/WHO-DD dictionary coding, and data visualization technology (Ex: Spotfire, elluminate, etc.);
- Experience working with MS Office Suite (Excel, Word, PowerPoint) and familiarity with MS Project;
Candidate Requirements:
- BS/BA with least 8 years of related industry data management experience in a biotechnology / pharmaceutical company;
- Provide leadership, representation, and guidance to the internal and external teams as the clinical data management subject matter expert for assigned program/studies
- Participate in and/or lead process improvements within data management / biometrics by authoring, reviewing, publishing, and reviewing policies and methods in standard operating procedures, work instructions, job aids, and other training documents
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
Top Skills
Cdash
Elluminate
Meddra
Ms Office Suite
Ms Project
Rave
Spotfire
Veeva Edc
Who-Dd
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