Clinical Study Manager - Uxbridge
Lucy Stendall at CK Group is recruiting for a two Clinical Study Manager's in HIV to join a world leading pharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
Stockley Park was the UK's first and most successful business park. Situated close to Heathrow Airport in West London, it is home for roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.
This Clinical Study Manager will work on close out and archiving of three outsourced studies (all have completed and CSRs in progress) and the outsourced Expanded Access Programme with a key asset Fostemsavir for ViiV Healthcare. This position is within the central Empowered Study Team (EST) who are UK/US based. Key duties include:
- Accountable to ensure all relevant studies follow SOPs and GCP.
- With direction, may matrix with key Study conduct partners.
- Assist with maintaining relationships and monitor performance of CRO's and other vendors.
- With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, and Operations Management) to ensure on time delivery of studies.
- Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
- With oversight manage study start-up, conduct and close-out.
- Manage clinical trial material.
- Assist in the management of CRO's or other outsourcing partners as appropriate.
- Provide input into content and execution of investigator meetings / may present selected topics.
- Provide input into development of CRF.
- Provide input into site selection with coordinated input.
To be a successful candidate you will have significant global study management experience managing outsourced studies and be a team player able to multitask across studies. Additionally, you should have the following skills, knowledge and experience:
- Degree in Life Sciences, Public Health or other related discipline with extensive clinical development experience.
- A background in clinical development sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience.
- Significant track record of global study management planning & delivery.
- Demonstrated ability to plan, organise and manage resources across a matrix organisation to bring to successful completion specific study goals and objectives in accordance with defined quality and time based metrics.
- Demonstrated expertise in the working with 3rd party suppliers.
Please note some flexibility is required to work with the wider global team in different time zones.
For more information or to apply for this position, please contact Jenni Woolley on 01438 768 710 or by email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43148 in all correspondence.