Clinical Research Study Manager

Hobson Prior are currently working with a leading pharmaceutical organisation who focus on preventing, diagnosing and managing diseases who are seeking a Clinical Research Study Manager. You will join them on a contract basis in Hertfordshire where you will provide leadership for one or more global Study Management Teams accountable for delivering internally managed as well as outsourced First in Man thru Proof of Concept studies.

Job Responsibilities:

• Leads the cross-functional Study Management Team (SMT).
• Responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting.
• Recognises key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.
• Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.
• With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms with Data Management, and necessary regulatory documentation following the provision of clear objectives.
• Conducts protocol and site feasibility assessments to ensure optimal site selection.
• Responsible for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving.
• Proactive management of all aspects of the study.
• Manages both internal and external partners.
• For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.

Key Skills:

• Capability representing the Study Management Group at Clinical Teams.
• Highly developed interpersonal skills and demonstrated business awareness.
• Effective leadership skill to lead cross-functional teams across multiple time zones.
• Highly effective verbal and written communication/presentation skills in English.

Requirements:

• Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline.
• Study management experience in clinical or pharmaceutical development.
• Extensive experience leading Phase I and Phase II studies.
• Working knowledge of international regulatory and ICH GCP guidelines.
• Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies).
• Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members.
• Direct experience overseeing multiple vendors and sites.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this 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.