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Job Details

Global Study Manager - Infectious Diseases

Company: CROMSOURCE
Location: United Kingdom
Reference: HQ00001360
Closing Date: 25 Jun 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Global Study Manager to work with one of our partner pharmaceutical companies in the Hertfordshire area.     This is a temporary position with TalentSource for 12 months with the possibility of being extended, on a full time basis. The Study Manager will be fully office based for the first three months, with some flexibility to work from home thereafter.

Requirements:

TalentSource Life Sciences is currently searching for an experienced Global Study Manager to work with one of our partner pharmaceutical companies in the Hertfordshire area.

This is a temporary position with TalentSource for 12 months with the possibility of being extended, on a full time basis. The Study Manager will be fully office based for the first three months, with some flexibility to work from home thereafter. The successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Position Purpose:

Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

This opportunity will be focused on the Infectious Disease therapy area.

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.
  • Analyses 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

Education / Qualifications:

Life sciences degree or nursing equivalent, or substantial experience in the clinical research environment.

Skills and Knowledge:

  • Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CRO's, drug supply management and planning operational activities to achieve database lock.
  • Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
  • Experience managing Infectious Disease studies.
  • Good knowledge of ICH GCP
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
  • Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels.

Why choose TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge

CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Keywords: Global Study Manager, Study Manager, Project Manager, Project Lead, PM, Global Project Manager, Study Leader, Study Lead, Clinical Research Manager, Clinical Study Manager, Clinical Project Manager, Clinical Trial Manager, Clinical Trial Lead, Clinical Research Lead, Contract Research Organisation, Outsourced, CRO, Pharmaco, Pharmaceutical, Oncology, Global, Studies, Study, International, Infectious Disease

Global Study Manager, Study Manager

Apply for this job: Global Study Manager - Infectious Diseases

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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