Clinical Research Study Leader

<b>Hobson Prior are currently seeking a Clinical Research Study Leader to join a global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. This position will provide leadership for one or more global Study Management Teams. Job Responsibilities:</b><br><br><b>Key Skills:</b><br><br><b>Requirements:</b><br><br><b>Apply now:</b><br><br>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.<br><br>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.<br>

<li>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.</li><li>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.</li><li>Recognises key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.</li><li>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.</li><li>Conducts protocol and site feasibility assessments to ensure optimal site selection.</li><li>Accountable for all aspects of study management.</li><li>Proactive management of all aspects of the study.</li><li>Manages both internal and external partners.</li><li>For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO.</li><li>Any other assigned duties.</li><li>Effective leadership skills.</li><li>Ability to lead cross-functional teams across multiple time zones.</li><li>Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline.</li><li>Study management experience in clinical or pharmaceutical development.</li><li>Working knowledge of international regulatory and ICH GCP guidelines.</li><li>Extensive experience leading Phase I and Phase II studies.</li><li>Experience in Phase II specific to more than one therapeutic area is preferred.</li>