Study Manager

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 pRED Study Management Team Leader.

Please note that to be considered for this role you must have the right to work in this location.

What you will be doing:
During your assignment you will participate as a member of the Study Management Team contributing to the delivery and execution of early phase study protocols.

You will:

• 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 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 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

Who are you:
You are talented and passionate. You are inspired by our mission and would t in well with our collaborative, patient-centric and entrepreneurial spirit.

• Having 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 has a passion for achieving successful outcomes and delivering excellence
• Want to make a difference and excitement in innovating practices and challenging conventions.
• Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.hobsonprior.com/privacy-policy.