Location: Ireland Dublin
Closing Date: 04 Dec 16
Type: Full Time
Salary (£): On Application
Job Summary: Novartis is currently recruiting for a Senior Clinical Project Manager to join the Clinical Trials team within the Novartis Global Service Center in Dublin. This is a brand new opportunity that has arisen due to the growth of the department. It offers global exposure and the opportunity to work on a variety of trials within various different therapeutic areas. ...
Novartis is currently recruiting for a Senior Clinical Project Manager to join the Clinical Trials team within the Novartis Global Service Center in Dublin. This is a brand new opportunity that has arisen due to the growth of the department. It offers global exposure and the opportunity to work on a variety of trials within various different therapeutic areas.
As a Senior Clinical Project Manager you will be accountable for all operational aspects of assigned clinical trials executed by PLS (Product Lifecycle Services) Pre & Post Launch Scientific Support Services on behalf of Novartis Organizations. You will lead Clinical Trial Teams responsible for full trial execution from protocol generation to clinical trial report/manuscript writing and publications and be accountable for ongoing and effective collaboration with Sponsor, Line Functions (medical writing, statistics, data management, monitoring, etc.) and third-party vendors.
About the Novartis Global Service Centre in Dublin:
The Novartis Global Service Center (NGSC), Dublin, was set up in 2013 and is located in a state-of-the-art facility on the Merrion Road in Ballsbridge. The center, one of five around the world, delivers a broad variety of services to the Novartis divisions and organizations worldwide. Services offered by the Dublin team include scientific and commercial services, IT, HR Operations and Procurement. There are currently several hundred associates employed at the site with 32 nationalities speaking 28 languages.
1. Agree with Sponsor team and Line Functions on realistic project and trial timelines. Lead the Clinical Trial Team and assigned resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
2. Accountable for the writing of clinical protocols and related documents in collaboration with the Product Lifecycle Services or Sponsor Medical representative as appropriate.
3. Accountable for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence.
4. In collaboration with the PLS or Sponsor Medical representative, lead the clinical trial or non-interventional study data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
5. Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab.).
6. Accountable for project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrollment.
7. Work with Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with PLS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance.
8. Accountable for the development, management and tracking of trial budget working closely with the PLS Finance and Sponsor representative.
Benefits of Working for Novartis
Competitive salary; Annual bonus
Pension scheme; Share scheme
Health insurance; 25 days annual leave
Flexible working arrangements
Subsidised dining facilities
Employee recognition scheme
‘I came for the job, I stay for the culture’ Minimum requirements 1.Extensive experience with Clinical Operations with extensive managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
2. Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
3. Good leadership, negotiation and project management skills
4. Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process for pre-approved and post-launch products.
5. Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
6. Strong customer oriented mindset
Novartis Pharmaceuticals UK Limited
Frimley Business Park
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