Associate Director, Clinical Operations Europe

Recruiter
Axess Ltd
Location
Berkshire
Posted
11 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Responsible for all aspects of clinical trial operational delivery for a series of Phase II to IV clinical trials, line management of clinical operations staff and providing functional back-up to the Head of Clinical Ops, Europe.

BACKGROUND

- Reports into the Head of Clinical Operations, Europe
- Position will suit a senior clinical operations professional who would relish the opportunity to take a leadership role in shaping the scope of this position, forming part of an entrepreneurial business and working closely with colleagues in the US in this highly visible role.
- Line management responsibility
- Well-funded specialist biopharma organisation, rapidly growing in Europe
- Lead asset in Phase III
- Earlier phase pipeline
- Central London location
- Opportunity to work from home one day a week

PRIMARY DUTIES

Responsible for:

Directs and manages the overall execution and delivery (programme management) of a suite of clinical trials to meet metrics, quality, time and budget specifications, undertaking trial activities where required. These activities include, but are not limited to:

- Managing and assisting the team to ensure activities such as the development of protocols, case report forms, investigator's brochures, consent forms, study manuals and specifications are completed in accordance with timelines
- Assuring timelines are developed for each clinical trial, communicated and managed in accordance with corporate timelines and goals.
- Assuring the clinical studies are adequately monitored, data are collected in timely fashion and cleaned for all trials.
- Assuring site selection activities are completed, appropriate information is collected and reviewed to enable timeline and efficient investigator selection
- Assuring all functions internal and external are set up and managed to enable efficient start-up of sites.
- Effectively interfaces with other functional departments (e.g. Data Management, Biostatistics, Safety, Program Leadership, Regulatory and CMC) to facilitate completion of cross-functional study tasks and enhance communication
- Assuring accurate estimates for clinical trial material needs are provided to CMC to plan for and adequately provision IP for each study
- Assisting with overall study budget development for new studies (e.g. CRO, Investigator fees, pass through fees) and providing information conjunction with the Finance Department.
- Ensuring the budgets for external services are tracked by clinical operations to provide status regarding contract to budget actual.
- Assist with budget forecasting and accruals as requested
- Responsible for the development, preparation, maintenance and adherence of team members to clinical operations SOPs.
- Provide regular updates and report on key milestones and study progress
- Close oversight and involvement of ongoing GCP inspection readiness activities
- Non-trial activities e.g. SOP writing/review, process improvement
- Non-CTA EU lead on Systems oversight (e.g. CTMS, eTMF)
- Line manage, develop and mentor a number of Clinical Operations staff
- Provide functional back-up and acts as a point of delegation to the Head of Clinical Operations, Europe

QUALIFICATIONS / EXPERIENCE REQUIRED:

- BS / BA (Life Sciences preferred)
- Significant experience in the biotechnology, pharmaceutical or CRO environment
- Strong leadership and team management skills and experience
- Extensive Vendor and Clinical Operations Management experience
- Management of Phase I-III clinical trials, including multi-center, and multi-country registration trials
- Experience with compliance issues, corrective action procedures and strong understanding of European and FDA Regulations, GCP and/or SOPs in a clinical operations context
- Contract management experience
- Experience of working with eTMF, CTMS and other electronic systems

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

Benefits:

Competitive including share options

TO APPLY:

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-7011.

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

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