CLINICAL STUDY MANAGER

The company

Our client, is a fast-growing biotech company. At only five years old they already have a development portfolio of six products. One is a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide. They also have an IPO behind them.

This exciting organisation is 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. They discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer.

Their achievements include co-inventing and jointly developing their COVID-19 vaccine candidate VTP-900, now Vaxzevria, which they assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. They have clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for their platforms.

From March 2022, their UK headquarters will be moving to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell, Oxford. They conduct research globally and have ambitious plans in the UK and US, where they will continue to grow their teams over the coming months and years.

The role 

The Clinical Study Manager will be responsible for the management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations. This will include study team coordination and leadership and the oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality.

You will hold responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs and will be responsible for the selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate. You will also select clinical sites in collaboration with other members of the Vaccitech study team or CROs, as appropriate.

The Clinical Study Manager will be required to conduct the periodic co-­monitoring with contract CRAs or CROs as necessary for each study, to ensure high quality monitoring and site management and to set up and management of clinical contracts (including Clinical Site Agreements). You will also be required to coordinate IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.

Experience and Qualifications

The successful candidate will be degree educated in a scientific discipline and have clinical study management experience within a pharmaceutical, biotech or a CRO company. You will have experience in the oversight of external vendors (CROs, central labs, imaging vendors, etc.). The ability to travel in the UK and abroad periodically if needed is essential.

Experience in early phase (I-­II) studies, GMO and CRA monitoring experience are desirable though not essential. Infectious Diseases and Oncology experience would be a distinct advantage.

What they can offer

They encourage an entirely flat structure with an open door policy to the senior leadership team. Their employees agree the culture and working environment is one of the best things about the business. As part of a small high growth business, you will get the opportunity to be involved in many different areas and their rapid growth trajectory, which means you will have the opportunity to grow with them. They offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 5% pension contributions matched by the company.