Consultant – Obstetrics and Clinical trial monitoring

Purpose of consultancy

To monitor the implementation of the WHO RED trial A66009 in Vietnam according to ICH Guidelines and HRP standard operating procedures.

Background

Postpartum haemorrhage (PPH) is the leading cause of severe maternal morbidity and mortality. The most common reason why mothers bleed after childbirth is uterine atony. Fortunately, the vast majority of women with PPH respond to first-line treatment interventions, including uterotonic drugs, uterine massage, and tranexamic acid. When first-line treatment fails, invasive therapies should be used, and hysterectomy is the ultimate measure for controlling the bleeding. Given that invasive surgery is not always available, it is a priority to investigate alternative non-surgical interventions such as the uterine balloon tamponade devices or other uterine tamponade procedures since those women who continue to bleed excessively, are the ones who suffer morbidity and mortality. Therefore, it is a global healthcare priority to conduct rigorous research and generate high-certainty evidence on the effectiveness and safety of uterine tamponade devices on treating PPH.

HRP will conduct an adaptive, hospital-based, multicentre, multi-arm, multi-stage (MAMS), individually randomized active-controlled superiority trial, to evaluate the superiority of pre-selected uterine tamponade (UBT) devices to treat refractory postpartum haemorrhage (PPH) compared to a control UBT device, to reduce severe maternal morbidity or mortality in women with vaginal birth experiencing atonic refractory PPH (the RED trial). The study will use a MAMS design to first identify the most promising device (Stage I) among three experimental devices, and then to test it in Stage II against the control device. At the end of Stage I, an interim analysis will be conducted, involving 680 randomized participants across all four trial arms. Data collected will be then analyzed to identify the best performing device, based on the observed decrease in the incidence of the primary outcome. The trial Stage I will be conducted in two hospitals in Vietnam.

The RED trial will be monitored in accordance with the ICH Note for Guidance on Good Clinical Practice (ICH Topic E6, 1996). Collected data will be regularly reviewed by the Trial Coordinating Unit (TCU) based at WHO Headquarters. Any abnormality detected at a participating hospital will be reported to the TCU. On-site monitoring visits by TCU members or delegates, will include an initial visit, two visits during the conduct of the trial and a final visit to close the trial sites. Additional monitoring site visits may be added as required. A standard operating procedure (SOP) for the monitoring visits will be developed specifically for this trial. Every aspect of the RED trial will be subject to Quality Assurance Activities, and audits may be conducted at any time to ensure the validity and integrity of the captured data.

Deliverables

• Deliverable 1: Provide trial clinical monitoring reports. Expected by: every month
• Deliverable 2: Provide site monitoring visits reports. Expected by: ten days after site visit is completed.
• Deliverable 3: Perform medical review of adverse and serious adverse events during the implementation of the trial. Expected by: throughout duration of the contract.
• Deliverable 4: As member of the Endpoint Review team, to review all events of maternal deaths, laparotomies, and near-miss events, to ascertain the relatedness with PPH.

Expected by: throughout duration of the contract.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• A first-level university degree in social or medical sciences.
• Postgraduate degree in public health.

Desirable:

PhD in clinical research.

Experience

Essential:

At least 5 years of relevant experience in clinical obstetrics.

Desirable:

Experience in conducting clinical trials.

Skills/Knowledge:

Clinical knowledge in postpartum haemorrhage and interventions to treat refractory PPH.

Languages required:

Essential:

• Expert knowledge of English and Vietnamese.

Note: Knowledge of Vietnamese language is also required. The consultant should interact with health providers who only speak and write in Vietnamese

Location

Off site: Home-based.

Travel

The consultant is expected to travel to Ho Chi Min city, Vietnam for site visits to RED trials participating hospitals, and travels to Geneva for trial coordination meetings and steering committee meetings may be required.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band B - USD 7,000 - 9,980 per month

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract(Maximum contract duration is 11 months per calendar year):

11 months part time at 25%. Remuneration will be pro-rated accordingly

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
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• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
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