Manager Clinical Research

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ABOUT US

L.E.A.F. Rwanda is a subsidiary of L.E.A.F. Pharmaceuticals a global pharmaceutical Company with a mission to discover, develop and commercialize innovative and safe therapies for cancer, autoimmune and infectious diseases.

L.E.A.F.  Pharmaceuticals is a fast-growing company with operations in Pennsylvania, Massachusetts, and the Republic of Rwanda. The organization offers employees a competitive salary and comprehensive benefits package, including paid time off and health insurance.

L.E.A.F. Rwanda Ltd has an immediate opening for a Manager of Clinical Research in Kigali, Rwanda.

Manager Clinical Research is a key strategic hire for L.E.A.F. Rwanda and an opportunity for a motivated individual to be one of the founding members of a team that establishes Clinical Research Operations for L.E.A.F. Rwanda, one of the first Biotechnology companies engaged in Drug Discovery and Development on the continent of Africa.  Manager Clinical Research will work closely with the team at the LEAF headquarters in Woburn, MA, USA.

The Manager Clinical Research is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Manager Clinical Research is required to lead a cross-functional team for the assigned clinical trials and is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with LEAF Standard Operating Procedures (SOPs), ICH/GCP and regulatory requirements. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Manager Clinical Research will contribute to and drive ongoing process improvement initiatives. May also be responsible for direct line management responsibilities and may be required to perform site management and monitoring activities for small studies.

Key Responsibilities

  • Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study or studies
  • Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
  • Provides input into baseline timelines and budget development
  • Oversees the execution of the clinical study against planned timelines, deliverables and budget
  • Provides operational input into development and writing of the protocol, informed consent form, and Investigator Brochure
  • Oversees and provides input to the development of study specific documentation including but not limited to, case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, etc.
  • Oversees the set-up of study management systems and maintenance study documents, as applicable
  • Ensures compliance with the clinical trial registry requirements
  • Leads risk assessment and identify risk mitigation strategies at the study level
  • Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation at the study level
  • Leads the feasibility assessment to select relevant regions and countries for the study for large global clinical trials
  • Oversees/conducts site evaluation and selection
  • Leads investigator meeting preparation and execution
  • Monitors progress for site activation and monitoring visits and acts on any deviations from the plan
  • Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from the plan
  • Ensures accurate budget management and scope changes for internal and outsourced studies
  • Escalates issues related to study conduct, quality, timelines or budget to Management and develops and implements appropriate actions to address issues
  • Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
  • Oversees and ensures the CROs and third-party vendors are in alignment and are delivering per the scope of work
  • Ensure clinical project audit and inspection readiness through the study lifecycle
  • Supports internal audit and external inspection activities and contributes to CAPAs as required
  • Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
  • Contributes to clinical study report writing and review
  • Facilitates and contributes to study level lessons learned
  • Recommends and participates in cross-functional and departmental process improvement initiatives
  • Responsible for mentorship and, if required, supervision of junior Clinical Trial Management staff; line management responsibilities may include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
  • Manager Clinical Research may be required to perform site selection, management, and monitoring activities for small regional studies. 

Job Qualifications

  • Effective project management skills, cross-functional team leadership, and organizational skills
  • Ability to understand and implement the strategic direction and guidance for respective clinical studies
  • A data-driven approach to planning, executing, and problem-solving
  • Strong knowledge of ICH/GCP, clinical trial methodologies and regulatory guidelines/directives
  • Experience in global clinical trial operations including experience developing protocols and key study documents
  • An awareness of relevant industry trends
  • Clinical trial budget management experience
  • Demonstrated clinical trials vendor management experience
  • Clinical trial site management experience, including site monitoring
  • Effective verbal and written communication skills, and presentation abilities
  • Technical proficiency in trial management systems such as IVRS/IWRS, CTMS, EDC and Microsoft applications including Project, PowerPoint, Word, and Excel
  • Ability to travel, both locally and internationally