Description
Accountabilities
Accountable for managing the planning, design, implementation, analysis and interpretation of the clinical pharmacology studies against agreed timelines, resources and cost, additional responsibilities include:
- Lead overall activities and optimize performance of the study team
- Negotiation of sufficient and appropriate internal and external resources for the Clinical Pharmacology studies.
- Ensuring appropriate representation for team discussions & decisions.
- Ensuring facilitation and co-ordination interactions and for gaining consensus within the Teams.
- Ensuring the timely and appropriate communication, and records, of Team discussions, decisions, requirements and progress against plan.
- Ensuring consistency and alignment of team direction with the overall aims of the study.
- Initiate contact and liaise with internal and external partners in order to support the effective delivery of a study or regulatory submission
Monitor study progress (eg patient recruitment, protocol compliance, GCP/regulatory compliance) and report status to the applicable team.
Track and manage study(ies) timeline according to agreed upon milestones, budget and resource; highlight significant variances to the Project Director and study team (when applicable)
Plan and monitor, investigational sites and study site meetings
Share knowledge, experiences and best practices with other members of the organization
Review and organize the review of data listings and tables (scientific content and data validation) with the study team.
As applicable, train internal and external personnel in the Study Management of Clinical Pharmacology Studies.
Responsibilities
Develop study synopsis and manage the development of protocols ensuring that there is input from all of the applicable functional areas (ie, medical, scientific and PK input.)
Forecast timelines, budget, materials and resource for assigned studies
Identify and communicate the potential impact of emerging results from studies that the contractor is supporting.
Participate in the training and mentoring of new Clinical Pharmacology Personnel.
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