Ref #: 29577

Employment type: Permanent - Full-Time

Location: Buckinghamshire

Posted: 28-May-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring an experienced senior study manager to join our Early Development Study team.

As a Global Early Phase clinical manager, you will drive the management of operational activities related to planning, implementing, executing, and reporting of clinical trials. You will be a core member of the Evidence Generation Team

Highlights of duties:

Operations Planning & Execution
• Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products
• Develops the strategic scenarios of designs for early phase clinical development plan as part of the EGP generation

Study Oversight & Execution
• Leads, manages, and monitors overall study related activities including:
o Issues related to patient eligibility, enrollment and protocol deviations
o Ongoing safety data review and completion of study data collection, data lock, and analysis
o Resolution of cross-functional study-specific issues
o Communication of study status to key stakeholder and updating relevant systems
o Ensures study personnel are appropriately trained and understand study timelines and deliverables
o Manages study budget & communication of budget changes
• Drives the writing and/or review of study design, synopsis, protocols, supplements, amendments and Investigational Product Instructional Manuals


What is required:

• Early development study management experience, ideally a minimum of 4 to 5 years
• Advance knowledge of first in human and early development study strategy & management
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Project and program management including oversight of study deliverables, budgets, and timelines
• Time, cost and quality metrics
• Key performance indicators (KPIs)
• Ideally MS, RN, or PharmD degree
• 7+ years of experience in a life sciences or medically related field, ideally gained within CRO, pharma or biotech
• Management experience of direct reports
• Experience in the oversight of Functional Service Providers, outside vendors (CROs, central labs, imaging vendors, etc.)
• Valid, current UK working eligibility


What is Offered

• Full-time homebased role
• Salary will be offered depending on level of experience and skills
• Permanent contract of employment with company perks and benefits
• Company benefits to include 25 days annual leave plus UK bank holidays, car allowance, bonus as well as pension, medical health insurance, etc.

Please contact me for more details at Elisabeth.Knighton@docsglobal.com

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