Study Manager - 1 year FTC in Welwyn

As a contract Study Manager you will be assigned to pRED early phase clinical studies, and as part of a cross‑functional study team, you will be responsible for delivering study management and clinical operations activities under the direction and leadership of a Study Management Team Leader. Through your direct study responsibilities you will also contribute to the management of external stakeholder relationships by helping Roche to be the preferred sponsor for sites, patients and other important healthcare providers.

What you will do / Expectations during your assignment:

• Deliver Study Execution by providing operational expertise into protocol design and feasibility, country selection, patient centricity and data delivery plans in partnership with cross‑functional stakeholders.
• Ensure study quality and integrity by developing and maintaining study systems and documentation (including informed consent forms, communication plan, Trial Monitoring Plan, Trial Master File etc).
• Provide Country Oversight, for insourced studies, by supporting or managing feasibility assessments to ensure countries and sites are selected for participation in studies.
• Provide guidance to country operational representatives during studies to ensure countries start‑up on time and deliver on their recruitment commitments.
• Manage Vendor Performance by providing direction and actively managing relationships.
• Ensure vendors and third‑party suppliers deliver against contracted scope of work and performance expectations and adhere to all appropriate standards (including ICH/GCP, SOPs and other regulations).
• Plan Demand and Supply by overseeing the forecasting and maintenance of supplies (including IMP) needed to ensure sites have the necessary resources to run clinical studies.
• Manage Risk and Compliance by assisting the study team in the identification, management and mitigation of study‑related risks and issues in your areas of responsibility (including oversight of the risk, action and decision logs).
• Drive Operational Excellence by providing operational expertise across a range of operations‑related activities that drive improvement and consistency in the execution of clinical studies.

How you will do it:

In Clinical Operations, mindset and behaviours are as important to us as skills and capabilities. You will succeed in the contractor Study Manager role by role‑modeling system thinking (connecting the bigger picture), agile behaviours (working flexibly, dealing with ambiguous situations, showing resilience), empowerment and accountability (using analytical thinking, tools, good judgement, and advice‑seeking to make the right decisions), a growth mindset (fostering an exchange of ideas and experimentation) and creating value (helping to connect peers’ work to a collective purpose).

Who you are:

• Have a growth mindset and are excited about learning through experience.
• Feel comfortable thinking on your feet and thrive in fast‑paced, ambiguous and highly collaborative environments.
• Hold a university degree or equivalent years of experience (preferred focus in life sciences).
• Have demonstrated strong and consistent performance as a Study Manager (or equivalent) in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus).
• A self‑starter who finds passion in achieving successful outcomes and delivering excellence.
• Want to make a difference and find excitement in innovating practices and challenging convention.
• Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines.

Location of the role:

Location of the role: Welwyn (UK) - presence in the office 3 days/week.

All qualified applicants for any employment position at Roche Products Ltd (and any sub‑companies of Roche Pharmaceutical Ltd, Roche Diagnostics Ltd or Roche Biomedical Ltd) will receive equal consideration, a consistent and respectful recruitment process, a fair audit of the performance of the recruitment process and the company's ongoing commitment to lawful diversity and inclusive employment across the globe.

At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.