Clinical Trial Manager

**Key Accountabilities**:
Trial Preparation
- Accountable for the trial activities for responsible R/OPU, including but not limited to;
- Creation, management and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
- Appropriate trial-specific training of R/OPU internal and external partners is performed in line with trial training plan.
- Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to verify trial team members are aligned and on track.
- Verifies and provides input into the country and site level feasibility and OPU commitment. Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions.
- Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value.
- Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to verify and leverage speed.
- Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.
- Verify timely responses to questions from Regulatory Authority/Ethic Committee and other external stakeholders

Trial Conduct
- Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring /mitigation. In collaboration with other functions, verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting.
- Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.
- Support CTL during investigator meetings
- Establish and maintain relationships with external experts, investigational sites, patient organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Clinical Development & Operations (CD&O) ad appropriate functions.
- Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence.

Trial Closeout and Reporting
- Verifies timely cleaning and delivery of clinical trial data.
- Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors.
- Verifies timely submission of the Clinical Trial Report (CTR) to Regulatory authority/Ethics Committee and other external stakeholders as required by local regulations
- Shares information on trial results with Investigational sites and, if applicable, patients

General Accountabilities
- Build and maintain engagement with Investigators, other site staff and patient organizations (POs), in collaboration with other functions, to verify trial speed and effective start up, conduct and close out.
- Establish and maintain relationships with external experts, investigational sites, patient organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions.
- Supports CTL to verify issues are raised to Evidence team for timely action or mitigation

Leadership competencies
- Creates an environment that inspires, motivates, and empowers colleagues and promotes one common Clinical Development and Operations (CD&O) identity, contributing to acceleration of clinical development timelines and value creation for patients.
- Fosters a learning culture in CD&O regions by encouraging continuous learning, sharing best practices, and learning from failures
- Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity.

Compliance with Parexel standards
- Comply with required training curriculum
- Complete timesheets accurately as required
- Submit expense reports as required
- Update CV as required
- Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements

**Skills**:

- Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
- Experience in Therapeutic Areas relevant in client pipeline is desirable
- Understanding of local/regional major regulations
- Familiarity with guidelines and standard of care is desirable
- Experienced in working with CROs and POs is desirable
- Ability to build and maintain strong relationships of mutual value
- Excellent influencing and communication skills

**Knowl