Study Manager

This job has now expired please search on the home page to find live IT Jobs.

Study Manager

Reading

Start date 1/3/19 (3-6 Months)

Pay: up to £450 per day

Job Purpose:

The objective of the Study Manager (STM) is to manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals

Key Responsibilities:

1. LEADER OF THE GLOBAL STUDY TEAM

* Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. Leads the yearly goal setting process for the study(ies) in scope in close collaboration with study team and all clinical team members

* Develops in cooperation with respective functions appropriate study related training for study team representatives and site personnel according to GCP and BAG

1 FEASIBILITY

* Supports protocol feasibility; leads the operational planning and tracking of the site feasibility

* Reports status, issues and important feedback to GCT

* Based on the feasibility summary, develops study timelines incl. enrollment projections, milestones and proposed external study budget

1 MANAGE STUDY ACTIVITIES

* The STM manages all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget

* Supports development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP

* Supports during Authority Inspections and internal audits and is responsible to get study conduct related findings solved

1 PREPARATION OF DOCUMENTS

* Provides operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team

* Develops the comprehensive overview and operational plans for the study such as the Study Plan, Oversight Plan etc

1 TRACKING AND REPORTING

* As a team member of the Global Clinical Team (GCT), the STM provides input to the GCT to enable accurate tracking and management of the overall Clinical Development Plan (CDP)

* Establishes study milestones with the study team and ensures accurate tracking and reporting of study metrics such as recruitment projections, patient enrolment, data cleaning progress and overall study progress

1 RISK IDENTIFICATION AND HANDLING

* Leads study risk levelling and risk mitigation strategies

* Contributes to risk management activities of GCT

* Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary

1 PLANS AND TRACKS STUDY BUDGET

* Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling

* Forecasting study budget in close cooperation with the Resource Management and System Integration (RMSI) group

1 MANAGE EXTERNAL VENDORS

* Acts as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.)

* Defines outsourced tasks and develops contract specifications for external supplier in collaboration with global strategic sourcing manager

* Performs ongoing vendor management, including negotiation of scope of work, budgets (incl. change orders), performance management, and issue resolution

Qualifications/Ideal Candidate:

* Bachelor's degree or equivalent education

* 7 years of relevant healthcare experience

* 3 years clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience

* In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations)