Clinical Project Manager

Clinical Study Project Manager – East Africa

Main Responsibilities

• Responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portions, per contract while optimizing speed, quality, and cost of delivery; ensure consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures.
• Set objectives for the core project team and/or sub-teams according to agreed contract, strategy, and approach; effectively communicate and assess performance.
• Collaborate with other functional groups within the company to support milestone achievement and manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively; lead problem-solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members, and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with the customer, owning the relationship with key customer contacts; communicate/collaborate with IQVIA business development representatives as necessary.
• Build the cross-functional project team and lead their efforts; manage cross-collaboration of the core team and oversee overall project delivery to support milestone achievement and manage study issues and obstacles.
• Ensure financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage the change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors, leading project vendor management and related activities as per project requirements.
• Adopt corporate initiatives and changes; serve as a change advocate when necessary.
• Provide input to line managers regarding project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.

Required Skills and Qualifications

• Education: Bachelor’s Degree in Life Sciences or related field.
• Experience: 5 years of prior relevant experience, including extensive experience in clinical project management.
• Regulatory Knowledge: Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements (i.e., ICH GCP and relevant local laws, regulations, and guidelines) towards clinical trial conduct. Experience with Regulatory and Ethics requirements in the region (East Africa).
• Therapeutic Area Knowledge: Knowledge in Malaria, Sickle Cell, and HIV.
• Communication Skills: Strong written and verbal communication skills, including good command of English.
• Leadership & Collaboration: Ability to work through others to deliver results to appropriate quality and timeline metrics, monitor/manage performance, provide feedback, and productively partner cross-functionally and with customers to advance work effectively and efficiently.
• Decision-Making: Ability to make decisions, bring clarity to disparate information to inform actions and drive results.
• Planning & Prioritization: Planning, time management, and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives, provide clear direction, and plan activities in advance considering possible changing circumstances.
• Results Orientation: Results-oriented approach to work towards delivery and output.
• Learning Agility: Demonstrated learning agility and openness to learning, keeping own knowledge and skill set current and evolving.
• Technical Skills: Good software and computer skills, including MS Office applications (Microsoft Word, Excel, and PowerPoint).
• Interpersonal Skills: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Cross-Cultural Awareness: Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Financial Acumen: Good understanding of project financials, including experience managing contractual obligations and implications.