Sr. Clinical Trials Associate
- Expired: over a month ago. Applications are no longer accepted.
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.
Responsible for supporting clinical study team(s) to manage various aspects of the operational execution and delivery of quality studies and quality processes according to protocols, SOPs, and company policies and procedures, applicable regulations and principles of GCP. Candidate should possess the ability to both prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment. Under the guidance of Clinical Operations management, the individual will coordinate, track, and manage daily activities for multiple clinical studies to support both the internal project team(s) and the CRO(s).
- Assist the Clinical Study Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.
- Inform the Clinical Study Manager/Project Team on any outstanding document(s).
- Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third party vendors.
- Participate in project management meetings and provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis.
- Support the Clinical Study Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.
- Communicate effectively with clinical study administration vendors (Functional Service providers etc.).
- Assist in coordination of Investigator and Vendor payments, tracking of payments and accruals, if applicable.
- Assist in data listing review and clinical study report listing review
- Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study is preferred. Associates degree with 5 years of clinical operations experience may be considered.
- Experience in managing eTMF platforms in an outsourced environment is required, with a minimum of 2 years of experience strongly preferred.
- Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices, and/or pharmaceutical products is required.
- Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and the ability to effectively manage multiple priorities in an environment under time and resource pressures are required.
- Familiarity with GCPs, ICH guidelines, and FDA regulations is preferred. Familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus.
- Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat is required.
- Strong skills with Microsoft Excel and SharePoint are required.
- Travel required < 5%.
AddressNew York, NY
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