Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
University of Washington Global Assistance Program Kenya
Clinical Trial Lead at Women’s Health Project, Mombasa
(1 Post)
Terms of employment:
Employment is a one-year renewable contract with a probation period for the first 3 months.
Research Project Description: The Women’s Health Project, based in Mombasa was established in 1993, and is a collaborative effort of the University of Nairobi (UoN), the University of Washington (UW), the Kenya Medical Research Institute (KEMRI), Mombasa County, the Ministry of Health, the Fred Hutchinson Cancer Research Center (FHCRC), and the US President’s Emergency Program for AIDS Relief (PEPFAR).
The objectives of the organization are:
To provide high quality care to at-risk and HIV-positive women participating in the high-risk women’s cohort (Mombasa Cohort).
To conduct innovative HIV and STI prevention and treatment research that will contribute substantially to local as well as global knowledge and implementation of effective interventions.
To support HIV and STI prevention, care, and research efforts in Mombasa by training Kenyan researchers and practitioners, implementing technology transfer, and contributing to infrastructure development.
The Role:
Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices.
Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.
Responsibilities
Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
Work closely with the Community Section Head to meet projects’ recruitment targets and ensure that appropriate recruitment strategies are in place
Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle
Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
Work closely with the Administrative Section Head, Vaccine and Treatment Evaluation Unit (VTEU) Manager, and VTEU Grant Specialist to manage clinical aspects of Project Finances.
Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
Collaborate with the clinical team to support milestone achievements
Report to internal and external stakeholders as per project scope requirements
Resourcing and Talent Planning of the clinical team.
Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
Conduct regular team meetings and communicate appropriately to achieve objectives
Support professional development by providing feedback to clinical team on performance relative to project tasks.
May mentor and coach new peers as they assimilate into this role
May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
Participate as a member of a leadership team that includes the PIs and heads of Administrative, Clinical, Laboratory, and Community sections of the project.
Required Knowledge, Skills and Abilities
Knowledge of clinical trials – Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct
Communication – Strong written and verbal communication skills including good command of English language
Problem solving – Problem solving skills
Organization – Planning, time management and prioritization skills
Prioritization – Ability to handle conflicting priorities
Quality – Attention to detail and accuracy in work. Results-oriented approach to work delivery and output
Leadership – Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
IT skills – Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Collaboration – Ability to establish and maintain effective working relationships with coworkers
Effective communication – Ability to influence without authority.
Minimum required education and experience
Bachelor’s degree in Medicine or Diploma in Clinical Medicine and Surgery with valid practice license
Requires 2 years of clinical research/monitoring experience or equivalent combination of education, training and experience
Experience leading clinical trials of drugs/vaccines is an added advantage
Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;
Requires broad protocol knowledge
Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
How to Apply:
Interested candidates are requested to email their application letter, detailed curriculum vitae and relevant academic and professional certificates with position title on the subject line, including names and contacts of three references, current and expected remuneration to f
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on or before
21st May 2021.
Only shortlisted candidates will be contacted.
