Research Fellow (Trial Manager, Botswana)

The International Society for Developmental Origins of Health and Disease (DOHaD); United Kingdom; Vor Ort; GBP 47.000 - 53.000; Vollzeit

Benefits dieser Stelle

Annual leave

Wellbeing days

Pension scheme

Zusammenfassung

London School of Hygiene & Tropical Medicine (LSHTM) is seeking to appoint a Trial Manager within the Clinical Research Department.

The post oversees ADVANCING-CM, a multicentre phase IIb/III randomised trial of adjunctive interferon gamma for HIV-associated cryptococcal meningitis across Botswana, Malawi, South Africa and Uganda." The successful candidate will be based full-time at the Trial Coordinating Centre in Gaborone, travel frequently to study sites, manage trial set-up, regulatory and

Qualifikationen

• Postgraduate degree in a relevant topic; doctoral level preferred.
• Experience managing multicentre phase III CTIMPs or similar trials.
• Strong knowledge of regulatory requirements and GCP.

Aufgaben

• Oversee day-to-day operational management of the trial across sites.
• Lead trial setup, regulatory and ethics processes, site initiation and monitoring.
• Ensure data quality, safety reporting and trial governance in line with the protocol and GCP.
• Coordinate documentation and communications among study sites and coordinating centre.
• Travel frequently to trial sites and manage cross-site coordination.

Kenntnisse

Trial management

Regulatory knowledge

Multicentre coordination

GCP experience

Ausbildung

Postgraduate degree (ideally doctoral)

Tools

CTIMP experience

GCP documentation

Jobbeschreibung

London School of Hygiene & Tropical Medicine (LSHTM)

Country

United Kingdom

Contract

Fixed-term

Type

Full-time

Research Fellow (Trial Manager, Botswana)

The London School of Hygiene & Tropical Medicine (LSHTM) is one of the world's leading public health universities. Our mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice.

LSHTM is seeking to appoint a Trial Manager within the Clinical Research Department. The post-holder will be responsible for the day-to-day operational management of ADVANCING-CM, a multi-site phase IIb into phase III randomised clinical trial of adjunctive interferon gamma for HIV-associated cryptococcal meningitis in Botswana, Malawi, South Africa and Uganda. They will work closely with the International Lead Clinician, the experienced senior trial management team and study coordinators at the participating African study sites. The post-holder will be expected to be based full-time at the Trial Coordinating Centre in Gaborone, Botswana for the duration of study recruitment and to travel frequently to the other trial sites. The role will provide operational leadership across trial set-up, regulatory and ethics processes, site initiation and monitoring, trial documentation, data quality, safety-reporting systems and trial governance, ensuring that the study is conducted in accordance with the protocol, Good Clinical Practice (GCP), applicable regulatory requirements and trial procedures.

The successful candidate will have a postgraduate degree, ideally a doctoral degree, in a relevant topic, relevant experience of working on multicentre phase III clinical trials, including Clinical Trials of Investigational Medicinal Products (CTIMPs), experience of trial set-up and site initiation, including preparation and maintenance of essential trial documentation, experience of clinical trial monitoring, including identification and follow-up of monitoring findings and protocol deviations. Further particulars are available in the job description.

The post is full-time 35 hours per week, 1.0 FTE and fixed term until 31 December 2030. The post is funded by Coefficient Giving and is available from 01 January 2027.

The salary will be on the LSHTM salary scale, Grade 6 in the range £46,643 - £52,909 per annum pro rata (inclusive of London Weighting). The post will be subject to the LSHTM terms and conditions of service. Annual leave entitlement is 30 working days per year, pro rata for part time staff. In addition to this there are discretionary "Wellbeing Days". Membership of the Pension Scheme is available. This post is based in Botswana, hosted by the Botswana Harvard Health Partnership Institute in Gaborone with frequent travels to sites in Malawi, Uganda and South Africa.