Global Studies Manager

Key People


Job ID :

14622


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,England,Greater London,


Key Skills :

Phase 2, Phase 3, Oncology


Salary :

£400 - £450 per day


Date Posted :

29 Mar, 2019



Company Name :

Key People


Location1 :

Greater London




Job Category :

Pharma Research & Development Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

100.00%





Description

Main Responsibilities and Accountabilities:

*Provides direction and leadership to one or more clinical operations teams
*Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
*Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
*Creates team culture and promotes team spirit.
*Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
*In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
*Oversees the development and maintenance of study specific manuals created by the GSA.
*Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
*Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
*Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the GSL.
*Establishes study milestones and ensures accurate tracking and reporting of study metrics.
*Provides operational input into the development of protocol feasibility questionnaires.
*Provides clinical operations expertise to ensure operational feasibility and delivery
*Leads the development and finalization of site feasibility questionnaires.
*Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
*Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
*Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
*Oversees forecasting of clinical/non-clinical supplies
*Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
*Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
*Delivers the operational elements of the study plan
*Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
*Ensures that reporting of SUSARs is established and maintained for the duration of the study.
*Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
*Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
*Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
*Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
*Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
*Provides operational input into the development and tracking of SMT goals.

*Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
*Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
*Develops and executes appropriate site and CRO/vendor audit and quality plans.

*Identifies areas of best practice and process improvements
*Participates in Pharma Development Operations initiatives and programs as assigned.
*Maintains oversight and ensures consistency of the operational aspects across studies within a project.
*Ensures study adherence to ICH/GCP and SOPs


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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