Clinical Operations Manager/ Clinical Trial Manager in Centurion, Gauteng at FHI Clinical Inc

Summary of The Position:

The Clinical Operations Manager (COM) provides leadership, training and oversight for Clinical Research Associates (CRAs) and supports the effective delivery of clinical trial projects. This role will collaborate with Clinical Operations Management staff to ensure the successful resource planning, staff performance management, and career development of CRAs. Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects. Also responsible for contributing to and participating in activities supporting marketing and business development.

The Clinical Trial Manager (CTM) will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical projects, including communication and interaction with clinical sites, CRAs and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and project accountability. This role will be responsible for the identification, resolution/mitigation and escalation of risks related to site management and monitoring of the trial.

Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), FHI Clinical policies and procedures. The COM works closely with the Clinical Project Managers, and cross-functional leaders to ensure the quality, timeliness, and efficiency of clinical operations.

CTM Duties:

COM Duties:

Line management for assigned CRAs in the following areas:

• Reviews quarterly Goals and Objectives for each direct report to document performance progress and career development.
• Evaluates and identifies resource issues and plans to resolve challenges. Understand and translate project budgets into baseline initial project staffing needs.
• Communicates with the Clinical Team Managers (CTMs)/Clinical Project Managers (CPMs), as needed, to ensure correct monitoring resources per project.
• Liaise with CTMs/CPMs to ensure monitoring deliverables/targets are met, ensure project hours are met, ensure excessive total hours are noted and action taken, as necessary.
• Manage personnel utilization and load balancing.
• Work with leadership in all applicable cross functional teams to support the continuous

• Analyze project resourcing, utilization, and realization data for validity of input/output produced;

• Ensures any project issues and results of discussions with CPMs are escalated appropriately.
• Assesses training requirements for monitoring staff and assures participation as needed.
• Conducts competency assessments during onsite or remote visits to verify competency and the effects of training on efficiency.
• Conducts regular one-on-one meetings with staff to discuss performance.
• Review and approve time sheets and expense reports as required.
• Coaches, trains, and supports direct reports.
• Provides staff with expert clinical research and therapeutic advice.
• Assists with Global Site Management teleconferences.
• Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
• Assists with the development and contributes to an effective orientation/on-boarding process for new Clinical Operations Staff.
• Maintains awareness of overall development in the field of clinical research and ensures that staff remain current on clinical monitoring developments.

Clinical Affairs Department Duties/Responsibilities:

• Assist with creating, reviewing, and revising departmental SOPs, working practices, and policies, as necessary.
• Support administration of recruitment for new personnel requisitions by translating unfilled staffing demand into FTE requirements and supporting updates to Line Management. Provides recommendations and/or decisions on new staff.
• Evaluates hiring and equipment needs and reports as necessary to leadership.
• Assists with the creation and delivering new department initiatives, improvement plans or
• Training.
• Assists Clinical Affairs leadership with Process Improvement Plans and other special projects as required by the department.
• Provides oversight of clinical projects to ensure quality of client deliveries.
• Manage escalations as per process and follow through to the resolution of issues.
• Collaborate with other departments and/or functional groups to ensure consistency of processes.
• May represent a functional area in internal or external audits.

• Other duties:
• Assist with marketing and business development activities, as required.
• Any other duties and responsibilities as assigned.

Knowledge, Skills, and Abilities:

Position Requirements

Education: Bachelor's Degree or its international equivalent in health, behavioral, or life sciences or related field; or an equivalent combination of education and relevant work experience.

Preferred Job-related Experience:

Technical Experience: At least 4 years’ experience in clinical development gained in a CRO, Pharmaceutical or Biotechnology company, with a solid understanding of the entire clinical research process and strong knowledge of global regulations. Prior Lead CRA experience is strongly preferred.

Leadership Experience: At least 2 years of personnel management or team leadership experience in a clinical research environment, including mentoring, performance management, and staff development.

Additional Eligibility Qualifications: Excellent organizational, communication (written and verbal), and interpersonal skills. Must be able to work independently, prioritize, and function effectively within a matrix team environment.

Preferences: Prior experience in electronic data capture (EDC), Clinical Trial Management Systems (CTMS) and eTMF is preferred. Prior vendor management experience is preferred.

Special Position requirements: Availability for extended hours in support of business needs across multiple time zones.

Physical Expectations:

Travel Requirements:

Availability to travel domestically and internationally is required. Expected travel time is less than 30% for this position. A valid passport and driver’s license must be maintained at all times.

This job description is not intended to be a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.