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Senior Manager, Clinical Operations - Oncology

Employer
GI Group
Location
England, Hertfordshire, Hatfield
Salary
Negotiable
Start date
20 Apr 2021
Closing date
18 May 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Senior Manager, Clinical Operations - Oncology
Permanent
Competitive Salary
Hatfield

Exciting opportunity to work for our International pharmaceutical client, who is looking for an experienced Clinical Operations Manager. You will be responsible for the leading the cross-functional study team in managing one or more clinical studies in Oncology, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. Ensuring that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Company standard operating procedures. Manages performance and development of assigned direct report(s).

Main duties and responsibilities:

* Has primary accountability for operational study level time, cost and quality deliverables
* Manages overall study budget - for large, global or multiple regional studies
* Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
* Executes work procedures in a project context. Consistently exercises judegment and discretion within generally defined procedures
* Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
* Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
* Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees.
* Coordinates all operational clinical research activities for regional / global studies
* Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
* Contributes to preparation of teams and documents for inspections
* Assesses risks and develops creative solutions
* Comprehensively assesses options to address study issues
* Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
* Selects / approves monitoring CROs and study sites
* Assists the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate

Skills & Experience required:

* Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
* Experience in clinical operations methods and processes in industry setting required
* BS/MS in relevant field
* Demonstrated experience in the pharmaceutical industry leading large, global studies with multiple vendors involving management of submission timelines and associated processes
* Solid project and vendor management, analytical and problem solving skills
* Prior experience with development and tracking of study budgets
* Excellent written and verbal communication skills

If you are interested in this role and feel that you have the right skills then please click apply.

For further details, please contact us on 01707 247259

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.

Company

Gi Group is one of the world’s leading staffing solutions companies, providing specialist services for the development of the labour market. Gi Group’s specialist Pharmaceutical Division supply high quality temporary and permanent staff to Pharmaceutical and Biotechnology organisations nationwide.

Gi Group’s Pharma Team can support clients onsite or remotely from Gi Group central offices and are specialists in their field with experience within the Pharmaceutical, Biotech and CRO industry.

The Group is active in the fields of temporarypermanent and professional staffing, search and selection, executive search, outsourcing, training, outplacement and HR consultancy.

Thanks to our direct presence and strategic partnerships, we operate in more than 40 countries across Europe, APAC, the Americas and Africa.

Able to serve all kinds of clients, the Group has developed strong expertise in large and multinational organisations, for which it has implemented global solutions through specialist divisions and dedicated local and international teams.

Ranked globally as one of the largest staffing firms by Staffing Industry Analysts, the Group is also a global corporate member of the World Employment Confederation (formerly CIETT).

Company info
Website
Telephone
01707 247259
Location
Gi Group - Pharmaceutical Division
James Taylor House
St Albans Road East
Hatfield
Hertfordshire
AL10 OHE
GB

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