Clinical Studies Leader
This is an excellent opportunity for a Clinical Studies Leader to join a large pharmaceutical company on 12 months contract with the possibility of an extension. The chosen candidate for delivery of global clinical studies to agreed timelines, budget and quality standards. If you think you are ready to take your clinical career to the next level then this might be the role for you.
- Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
- Lead and facilitate communication across all functions. Lead and conduct investigator meetings and other study related meetings.
- Provide input into and hold accountability for the development of essential study documents in accordance with relevant SOPs.
- Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget. Ensure adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
- Develop and maintain relevant study plans as well as detailed and realistic study timelines.
- Accountable for ensuring that all systems utilized at a study-level (e.g. ACCORD, PharmaCM, etc.) are maintained.
- Accountable for leading the identification of overall study-level risk management activities. Ensure mitigation strategies are implemented effectively and that issue escalation pathways are clear to the entire study team.
- Oversee study level performance against agreed upon plans, milestones and key performance indicators. Communicate key risks and proposed mitigations to applicable stakeholders.
- Maintain oversight over quality issue reporting in accordance with relevant SOPs and collaborate with all functions and/or external service providers as necessary to implement corrective and preventative actions.
- Oversee Trial Master File (TMF) completion from study start until archiving, in accordance with relevant SOPs.
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Clinical Trial Transparency, etc.).
- Accountable for study budget management (and re-forecasting where required) through the study lifecycle. Provide budget progress reports and highlight financial risks and mitigation plans.
- Oversee individual performance of study team members and ensure resource is utilized efficiently. Identify and communicate resource gaps for assigned studies. May mentor less experienced colleagues.
- Work on non-drug project work such as process improvements as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.
Skills and Requirements
- Must have 3 years Clinical Trial Assistant experience.
- Scientific background is desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.