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Clinical Trial Manager

Há 1 mês

Lisboa, Portugal Novasyte Tempo inteiro

Join us in our exciting journey

IQVIA is expanding in EMEA We currently have a Regional CPM to work sponsor-dedicated to one of our pharmaceutical clients

The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

The CTM provides leadership and direction to the R/OPU trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx). They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a regional/local and global level.

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.

Essential Functions- Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.- Creation, management and review of the R/OPU trial budget to ensure 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 ensure trial team members are aligned and on track.- Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).- 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 ensure and leverage speed.- Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.- Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.

**Qualifications**:

- Bachelor's Degree Life sciences or related field Req
- Requires greater than 7 years clinical research experience including 4 years project management experience or equivalent combination of education, training and experience.
- Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.;
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Communication - Requires strong negotiation and customer management skills.
- Problem solving - Strong problem solving skills.
- Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross
- functionally and with customers to advance work effectively and efficiently.;
- Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.;
- Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
- Prioritisation - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
- Quality - Attention to detail and accuracy in work.
- Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to l