Consultant - Clinical Research

Purpose of consultancy

To provide technical expertise to the preparatory and implementation phases of the WHO PPH treatment trial, according to ICH Guidelines and HRP standard operating procedures.

Background

Postpartum hemorrhage (PPH) is the leading cause of maternal death globally. Women who survive PPH often suffer acute or longer-term disabilities that may impact on their future health and well-being and reproductive functions. The majority of maternal deaths associated with PPH occur in low- and middle-income countries, especially in sub-Saharan African and Southeast Asia, and are largely preventable with appropriate interventions. Oxytocin is the uterotonic recommended by WHO for the prevention and treatment of PPH. However, oxytocin is a drug that needs to be transported and stored continuously at 2-8°C to preserve its activity. Many settings in LMIC countries do not have consistent cold chain systems for medicines, and therefore the quality of oxytocin cannot be guaranteed. A uterotonic that is stable at room temperature, and that is as safe and effective as oxytocin for managing PPH would be of great benefit for these settings. To address this gap in the global response to the public health shortcoming, HRP will conduct a multi country randomized clinical trial to generate evidence on the efficacy and safety of heat-stable carbetocin (HSC) compared to oxytocin when used as ‘first line’ uterotonic for PPH treatment. The results of this trial, if positive, will be used for extending the indication of HSC to include PPH treatment. Therefore, the trial must be fully compliant with Good Clinical Practice guidelines (GCP) as defined by the International Conference on Harmonization, as well as with applicable regulatory requirements from Stringent Regulatory Agencies. The research evidence generated will contribute to build an evidence ecosystem that will enable the right conditions for expanding the access of HSC in low resource settings.

Deliverables

The consultant will contribute to the preparation and conduct of the trial ensuring that the trial milestones are achieved in a timely manner and as per trial budget.

• During the Trial setup the consultant is expected to:
  • Provide technical expertise to trial sites in the preparation of the trial master file and investigator’s brochure.
  • Provide technical guidance to the clinical research organization (CRO) in the trial preparatory activities at each of the participating sites, including adaptation of the informed consent and other trial documents as per local sites’ standards.
  • Prepare the trial monitoring plan.
  • Provide guidance on the design of the trial treatment label according to stringent regulatory authorities' requirements.
  • Organize the shipment of trial treatment packs considering sites’ recruitment rates and drug expiration dates.
• During the Trial implementation the consultant is expected to:
  • Provide technical guidance to the trial coordinating unit to ensure that the trial is implemented in a timely manner and as per project budget, by monitoring and forecasting recruitment rates, and defining contingency plans for improving performance where needed.
  • Contribute to the dissemination of research notifications related to the trial by preparing information notes on the progress of the trial.
  • Contribute to the trial’s close-out activities by arranging archiving of trial materials and trial master file.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• University degree in life science or administration, with training in clinical trials management.

Desirable:

• Master's degree in health research or certification in trial management.

Experience:

Essential:

• At least 5 years of relevant experience in collaborating in health research studies.

Desirable:

• Experience in maternal health research, including postpartum hemorrhage.

Skills:

• Effective communication, organizational and planning skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to establish and maintain effective working relationships with people from different cultures.
• Multitasking and execution skills.
• Good organizational skills, including efficiency and collaboration in a team environment.
• Proficiency with computer skills.

Languages required:

Essential:

• Expert knowledge of English.

Location

Off site: Home-based.

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level 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:

11 months – part-time at 50%. 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.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• 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.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html