Associate Director, Clinical Data Management
- Posted: over a month ago
Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.
In December 2021, Vaccitech acquired Avidea Technologies Inc. with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us U.S operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. Vaccitech's UK headquarters has recently moved to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
Manage all aspects of clinical data management support for assigned Vaccitech trials:
- Oversee DM-related responsibilities, including protocol development, trial start-up, database training, case report form (CRF) development, database build, edit checks, query resolution, data transfers, database lock, and all associated documentation for electronic trial master file (eTMF) filing
- Identify potential issues for clinical development programs and associated trials, and provide data management expertise for relevant issues, as needed
- Provide oversight of outsourced DM activities, including vendor and electronic system selection, coordination with other functional areas, and management of overall timelines, contracted budgets, resources and quality
- Establish and maintain vendor governance and oversight tools, such as metrics to assess quality and timeliness of vendor DM-related deliverables, to facilitate appropriate DM vendor selection across Vaccitech’s clinical development programs
- Perform senior-level review of all DM-related documentation pertaining to assigned clinical trials, such as drafts of final protocols, data management plans (DMPs), CRFs, and CRF Completion Guidelines (CCGs)
- Act as a liaison between data management CROs and the CD team, in particular Clinical Operations and Biostatistics, by providing guidance on data management tool selection, such as eCOA/ePRO and eDiary, resourcing, timelines, CRF design, and database development support across clinical trials
- Maintain DM-related eTMF materials for assigned clinical trials
- Ensure CDISC/CDASH standards are applied by DM vendors
- Ensure compliance with departmental SOPs
- Assist in selecting, evaluating, and implementing tools and/or systems to improve the quality and efficiency of DM related deliverables and tasks, as needed
- Assist with data transfer agreements and data reconciliation
- Assist QA department on relevant guidelines and SOPs
- Keep up to date on new data management tools and regulatory norms
Qualifications and experience required
- BS or BA degree and at least 6 years of experience in clinical data management or a related field for Senior Manager or 8 years for Associate Director level
- Experience with current EDC systems and data collection tools
- Familiar with vaccine and oncological trial designs
- Excellent command of English and good communication skills
- Expected Vaccitech norms of collegiality, integrity, and transparency
What we can offer you
Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer employer funded health, dental and vision insurance; a 401k retirement plan; career development opportunities and paid time off (PTO). Salary will be commensurate with experience.
Notice to recruiters
Vaccitech’s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.
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