Project Manager - Temporary

Fred Hutch; Cape Town; On-site; ZAR 600,000 - 1,000,000; Full time

Job summary

A leading cancer research organization seeks a Clinical Research Manager to oversee operations, quality assurance, and staff management across multiple research projects. The ideal candidate will have a background in health sciences and extensive experience in clinical research management. This role requires strong leadership and communication skills to ensure compliance with regulatory standards and successful project outcomes.

Qualifications

• At least 5 years in managing multiple research projects in a leadership capacity.
• Clinical research on-site management experience.
• Excellent report writing skills.

Responsibilities

• Coordinate development and implementation of site standard operating procedures.
• Oversight for adherence to NIH and network policies.
• Manage staff performance and development.

Skills

Communication

Teamwork

People Management

Analytical Thinking

Problem Solving

Education

Tertiary degree in a health sciences related field

Masters degree preferred

Job description

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The main purpose of this position is to provide strategic operational and resource management and support of research studies and maintain financial effectiveness of research sites, oversight of network clinical operations and management of project teams, and investigating all possibilities of sustainability, including expansion into other NIH networks.

Responsibilities

Operations (Network and CRS)

• Coordinate the development, implementation and maintenance of site standard operating procedures (clinical, regulatory, safety, recruitment and retention, financial, laboratory, pharmacy) and data and quality management plans which adhere to sponsor requirements, local regulatory guidelines and good clinical practices.
• Oversight for adherence to NIH and network policies and procedures with respect to site accreditation, protocol activation and study implementation.
• Implement and monitor deliverable timelines for clinical operations, data entry and quality management, as agreed upon by study leader and management team.
• Responsible for documenting operational and quality issues that arise and feed back to appropriate line managers.
• In coordination with the study management team, implement, maintain and evaluate the clinical quality assurance process, specifically relating to protocol adherence and data quality.
• Develop and deliver progress reports, proposals, study documentation and presentations to sponsors, UCTCTU Steering Committee, Ethics, Regulatory and other stakeholders.
• Give support to Study Coordinators to optimally conduct the study protocol in line with sponsor and regulatory requirements.
• Assist Study Coordinators to ensure that specific administrative, operational and clinical policies are adhered to for their staff including evaluation and retraining where indicated.
• Oversee external evaluation monitoring (Clinical Trial Monitors) and manage the resolution of all queries.
• Annually: participate in study management consolidation. Assess and develop “other” resources requirement plans as per research budgets/projects, ensuring optimal and efficient procurement and utilization of all other resources.
• Participate in the identification and management of strategic operational site requirements, e.g. space requirements, renovations, fundraising needs. Bi-annually: review and update actual resource utilization against plans.
• Coordinate staff requirements and recruitment for study specific activities.
• Assist with coordination of staff training and development needs.

Staff management includes:

• Line management of study staff (Laboratory personnel, Study coordinators, Community Liaison Officer and Engagement Advocate).
• Monitor roles and responsibilities for study staff. Ensure that all staff are adequately trained and that certification is current on GCP, protocol training and SOPs.
• Ensure that study staff are developed to their full potential by identifying training needs and coordinating training and development.
• Manage the performance appraisals of all line management, including agreeing on objectives, assessing competencies against objectives, drawing up a development plan if needed.
• Through mentoring and interaction, develop action plans to resolve barriers to performance.
• Assist with study staff interviews and disciplinary hearings.
• Ensure that study staff render a service to all stakeholders of an acceptable standard and that they work within organizational policies & procedures AND NIH policies and regulations.
• Ensure fair allocation of workload amongst portfolios.
• Develop specific goals and plans to prioritize, organize, and accomplish work.
• Monitor operational study activities.
• Schedule study staff leave and maintain staff records.
• Ensure effective communication with managers of multifunctional staff.

Study Protocol Implementation and Execution Specific to GSH CRS Work

• Ensure that specific administrative, operational and clinical policies are adhered to for multiple studies.
• Manage and perform study procedures in compliance with regulatory and ethical standards, as well as study protocols.
• Oversight of screening, consenting, enrolment and follow-up of participants.
• Oversight of line management and staff to coordinate day to day activities as required by protocol (booking participants, clinical procedures, documentation, clinic flow, etc.).
• Participate and provide feedback in conference calls, local and international meetings.
• Act as back-up Study Coordinator, for all studies, when required.
• Work with Quality Control Officer to ensure that Quality Control and Quality Assurance activities are conducted as per Quality Management Plan.

Maintain Unit Viability Through Research Support

• Provide input on protocol and protocol revision as required and ensure staff are trained on updates.
• Host visitors to the research site, including investigators of other studies.
• Manage CTAC and other relevant studies Community Engagement Team, including stakeholder engagement and relationships with other Key Populations and organisations.

Qualifications

MINIMUM QUALIFICATIONS:

• Tertiary degree in a health sciences related field
• Professional registration/License as appropriate to qualification
• At least 5 years in managing multiple research projects in a leadership capacity
• Clinical research on-site management experience
• Staff performance management and development
• Excellent report writing skills

PREFERRED QUALIFICATIONS:

• Masters degree preferred
• Communication, teamwork, people management, clinical research and quality management experience.
• Knowledge of South Africa Clinical Research Regulations.
• Experience with Division of AIDS.
• Analytical thinking / problem solving
• Building interpersonal relationships
• Communication
• Quality commitment / work standards
• Meeting facilitation /leadership participation
• People Management
• Planning and organizing / work management
• Research Support skills

Protection of Personal Information Act (POPIA) Consent to Use and Collection of Personal Information, Including Consent to Background Check.