CLINICAL OPERATION LEAD
Likak Research
Nơi làm việc
Dakar
Hình thức tuyển dụng
Toàn thời gian
Chi tiết công việc
PURPOSE
As the clinical trial liaison to the Project Manager, the Clinical Operations Lead manages the
clinical aspects of the trial and has a direct impact on the projects, teams, and clients for the
benefit of the patients we serve.
The Clinical Operations Lead has overall responsibility for the execution of the clinical
operations strategy on the project. He/she is responsible for the coordination of the functional
team members and their activities across all geographical regions and liaises with project
management and/or the sponsor to ensure that the expected outcomes of the global research
operations (schedule, quality, productivity) are met.
RESPONSIBILTIES:
Duties include and are not limited to:
• Working with management to develop policies, forms and procedures for staff
members to follow.
• Ensuring that clinical operations staff are trained on all necessary documents, tools and
new technologies being implemented in the department.
• Supervise and coach all clinical Operations staff and measure their performances.
• Likak’s liaison to oversee quality and timeliness to meet sponsor requirements.
• Monitoring patient satisfaction scores to determine if they are meeting standards.
• Creating reports on the status of operations at all facilities where the company provides
services.
• Reviewing patient records to ensure that all required procedures were followed during
patient care.
• Facilitating communication between relevant staff members, such as nurses and
physicians, to ensure that patients receive quality care.
• Maintaining accurate patient data on charts, medical records, and computer databases.
• Managing the facility’s inventory of supplies, including medications and lab
specimens.
• Creating new programs or processes to improve efficiency or effectiveness of
operations within a facility.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• In depth knowledge of, and skill applying, applicable clinical research regulatory
requirements, i.e., Good Clinical Practice (GCP) and International Conference on
Harmonisation (ICH) guidelines.
• In depht therapeutic and protocol knowledge as provided via company training
• Computer skills including proficiency in use of Microsoft Word, Excel and Powerpoint
and use of laptop computer.
• Strong written and verbal communication skills, including good command of English
language.
• Demonstrated team leadership and mentoring skills.
• Ability to develop and deliver project and functional training.
• Excellent planning, organizational and problem-solving skills.
• Ability to manage competing priorities and ensure on-time, high quality delivery of
project tasks/responsibilities.
• Ability to establish and maintain effective working relationships with co-workers,
managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Master’s degree in health ad ministration or other scientific discipline or educational
equivalent and a minimum of 5 years of onsite monitoring experience; or equivalent
combination of education, training and experience.
• Extensive Project Management or Clinical Operational Management previous
experience
PHYSICAL REQUIREMENT
• Extensive use of telephone and face-to-face communication requiring accurate
perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Regular travel to research facilities, as required.
OTHER REQUIREMENTS
• Clinical Operation Lead reports to Likak CEO
• It is strongly recommended that the COL works primarily from Likak Research's
headquarters in Dakar, Senegal. Although remote working is also accepted.
EVALUATION CRITERIA FOR THE POST
• Monitoring Visit reports reviewed and submitted to client in a timely manner
• Likak monitors coached adequately
• Trials well overseed for quality and metrics
• Be the Clinical Trial quality officer liaison between sponsor and Site Team
• Evaluation of monitor deviation, creation and management of CAPAs
• Coordination of work with other Likak departments and colleagues
