Clinical Project Lead

Involvement in the country and site selection process together with the Registries Team, Local Medical Affairs.

Arrange supply of necessary Registry materials e.g., Protocols, Case Report Form (CRFs), Protocol Agreement Forms (PAFs) etc. for ethical and regulatory submissions (where applicable)

Ensure a financial contract is executed for each site and assist with the contracting process itself.

Responsible for all the Registries in the assigned countries.

Maintain oversight of the Registries and provide country status to Global Registries Team.

Coordinate and collaborate with the Clinical Research Associates.

Registries Oversight in a matrix environment.

Review and approve site visit reports (Site Selection, Site Initiation, Routine Monitoring and Close Out Visits), follow-up letters (as needed), etc.

Monitor contract related issues and arranges payments in accordance with agreed upon payment milestones for each individual site, following the status with the Finance team.

Monitor data quality (including contact with data management) and prepare project tracking and reporting systems.

Coordinate international data collection projects.

Give input to align activities with Clinical Project Leads of other Regions within the scope of the Global Registries Program.

Liaise with Medical Affairs Teams in the countries for any applicable topic.

Implement and perform miscellaneous projects or administrative tasks.

Liaise with vendor for different activities (startup, onsite monitoring).

Assure adequate safety reporting process according to country regulations and SOPs.

Quality control of study conduction at country level - with "audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.

Responsible for training or arrange training for new CRAs.

Responsible for Training (train the trainer) additional resources hired on a temporary basis in the countries.

To maintain tables, trackers, and databases to follow the study progress locally and globally.

To know and use all the tools needed.

Support the improvement of internal processes by providing feedback on e.g., CAPA, and (re)writing Quality Management System (QMS) and/or project specific documents.

To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in filing country documents as required.

Study Meetings: To participate with the rest of the study team in local and international investigators meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

Performance: (1) Strategic Planning: Developing comprehensive plans for the initiation, execution, and completion of registries, ensuring alignment with project goals and timeline (2) Team Leadership: Leading and coordinating cross-functional project teams, ensuring effective collaboration and communication among team members (3) Regulatory Compliance: Ensuring that registries comply with national and international regulatory requirements, including ICH/GCP guidelines. (4) Problem-Solving: Addressing and resolving issues that arise during the registries, using strong problem-solving and decision-making skills. (5) Stakeholder Communication: Maintaining clear and effective communication with all stakeholders, including sponsors, vendors, regulatory authorities, and the research team (6) Monitoring and Evaluation: Regularly monitoring the progress of the registries and evaluating the performance of the registries team, making necessary adjustments to ensure project success.

Process: (1) Involvement in the country and site selection process together with the Registries team and Local Medical Affairs. (2) Arrange supply of necessary Registry materials e.g., Protocols, Case Report Form (CRFs), Protocol Agreement Forms (PAFs) etc. for ethical and regulatory submissions (where applicable). Ensure a financial contract is executed for each site and assist with the contracting process itself. (3) Responsible for all the Registries in the assigned countries. Maintain oversight of the Registries and provide country status to Global Registries Team. Coordinate with the Clinical Research Associates. Review and approve site visit reports (Site Selection, Site Initiation, Routine Monitoring and Close Out Visits), follow-up letters (as needed), etc. Monitors contract related issues and arranges payments in accordance with agreed upon payment milestones for each individual site, following the status with the Finance team. Monitor data quality (including contact with data management) and prepare project tracking and reporting systems. Coordinate international data collection projects. Give input to align activities with Clinical Project Leads of other Regions within the scope of the Global Registries Program. Liaise with Medical Affairs Teams in the countries for any applicable topic. (4) Assure adequate safety reporting process according to country regulations and SOPs. Quality control of study conduction at country level - with "audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. (5) Responsible for training or arrange training for new CRAs. Responsible for Training (train the trainer) additional resources hired on a temporary basis in the countries. To maintain tables, trackers, and databases to follow the study progress locally and globally. To know and use all the tools needed. Support the improvement of internal processes by providing feedback on e.g., CAPA, and (re)writing Quality Management System (QMS) and/or project specific documents. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in filing country documents as required. Study Meetings: To participate with the rest of the study team in local and international investigators meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

Stakeholder: (1) Commit to Customers - Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Operations function. (2) Effective communication to stakeholder which involves determining the best methods and frequency of communication for each stakeholder group regarding regular updates. (3) Actively involve stakeholders in the project planning and decision-making processes. Continuously monitor stakeholder engagement and satisfaction. Address any concerns or issues promptly to maintain positive relationships. This also involves being adaptable to changing stakeholder needs and project dynamics. (4) Collect feedback from stakeholders regularly and use it to improve project processes and outcomes.

Experience :

Soft skills :

Technical skills :

Education : Degree in a Pharma/scientific discipline or a related Life science degree, with substantial project management or clinical trials and drug development experience.

Languages : High Proficiency in written and spoken English.