Clinical Study Manager: HIV
- Brentford, Greater London (GBR)
- £400 - £440 Per Day
- 6 Months
- Start date: ASAP
- Ref: CLINICALSTUDHIV
- clinical study
- statistics
- sops
- protocol
- hiv
- archiving
- monitoring
- reporting
- outsourcing
- healthcare
- operations management
- compliance
Clinical Study Manager: HIV
Global Clinical Study Management of four late phase HIV studies (inhouse and outsourced) currently in maintenance/close-out stages.
- With direction from senior clinical staff, collaborate with clinical operations functional groups (regional monitoring (inhouse studies), data management, statistics, clinical supplies and operations management teams) and service providers/vendors to ensure on time delivery of studies to required quality standards.
- Outsourced studies:
- Work closely with the CRO study/project managers and address any study related questions, address issues related to study drug supply.
- Assist in the management of CROs and/or other outsourcing partners as appropriate. This would include global CRO contract renewal/extension, additional vendor contracting, management and oversight.
- Maintaining relationships and monitor performance of CRO's and other vendors as appropriate.
- Inhouse studies:
- Work closely with the local operating country study managers and address any study related issues.
- Maintaining relationships and monitor performance of vendors as appropriate.
Manage study conduct and close-out activities including:
- Medical writing:
- Clinical study report writing
- Protocol and ICF amendments as appropriate
- Country and site close out, including managing patients transitioning from study to commercial supplies.
- Ensure accurate maintenance and archiving of study records including eTMF.
- Escalate issues as needed to the Clinical Delivery Lead/Medical Monitor.
- Manage the storage of retained human biological samples from ongoing and additional closed studies including maintenance of trackers and manage invoicing.
- Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
- Accountable to ensure compliance with GSK and CRO SOPs (as appropriate) and GCP.
- Oversight of final close out of studies (in last stages of close out/reporting) to required SOPs/Policies and standards. This would include the transition of subjects to commercially available product on a by country basis and supporting countries in implementing local strategies.
This role will be working on GSK inhouse and outsourced studies with key HIV assets for ViiV Healthcare. It can be US or UK based. The successful candidate will have global study management experience in clinical operations, be a team player with a focus on excellence and proven operational delivery. They should have an aptitude for clinical systems, can do attitude, with the ability to work across studies within a complex matrix and fast paced environment. Some flexibility is required to work with the wider global team in different time zones.
Experience in medical writing (i.e. study report generation) is desired. Previous HIV or GSK experience would be preferable but is not essential.
