Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
SUMMARY
Sr. Manager, Clinical Data Management is independently responsible for oversight of data management activities for clinical and pharmaceutical trials of all phases; work collaboratively to make sure the deliverables and timelines are met and that data is collected, managed and reported clearly, accurately and securely.
RESPONSIBILITIES
- Primary contact between DM and clinical study teams for the assigned studies. Liaises directly with internal teams of Medical, Clinical Operation, Project Management, Biostatistics, Quality Assurance, and Regulatory Affairs as well as external vendors to coordinate all aspects of data management for assigned studies.
- Manages CRO for DM activities and deliverables in conjunction with the study team. Communicates priorities, project plans, scopes and changes with DM CRO.
- Serves as Subject Matter Experts (SMEs) for Data Management from protocol review to database lock.
- Ensures project deliverables and proposes solutions for data management issues that arise during the study.
- Accountable for the development and execution of Data Management project plans including timelines/milestones, quality control, database set-up, study conduct and closeout. Accountable for overall quality of deliverables from DM vendors per Zentalis standard requirements.
- Manages vendor performance and quality and escalates to vendor managers and Senior Management, as necessary.
- Communicates project status and vendor performance in relation to both quality and timelines to both sponsor and the vendor management. Develops risk mitigation or action plans where appropriate.
- Participates in the review of protocols and other study related documents as required.
- Assures that data management standards and SOPs are followed for the responsible studies.
- Manages complex trials and partnerships; acts as a DM consultant on special initiatives both inside and outside the Data Management department.
- Other assignments as assigned.
QUALIFICATIONS
- 7 – 10 years of experience in the Data Management field, experience of managing CROs and Data Management vendors is required, working in a global/cross cultural setting is preferred.
- In-depth knowledge and understanding of the drug development process and data management process. Aware of related Pharma Industry guidelines and Best Practices
- Knowledge of GCP, CFR 21 and other regulations. Aware of current global regulatory guidelines relevant to Clinical Data Management.
- Technical/Software Skills: Familiarity with Electronic Data Capture tools; General software skills: MS Word, MS Excel, and MS Project.
- Knowledge of Coding
- Excellent oral and written communication skills and presentation skills.
- Ability to manage multiple studies and processes simultaneously and under tight timelines.
- Proven ability to build relationships and manage expectations with CROs and clinical team of multiple functions.
- Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem-solving ability, ability to develop trust, shared goals and values.
- Exhibits collaborative thinking, and accountability to deliverables milestones, conflict resolution (internal and external).
- Demonstrates negotiation and problem-solving skills.
- The candidate should be detail oriented, identify issues and assist in problem solving in a timely manner.
- Ability to work independently with minimal supervision in a fast-paced environment.
- Oncology Study experiences are a plus.
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