Clinical Project Lead

Job title:Clinical Project Lead

• Hiring Manager: Project Lead – ESR and Grants

• Location: Hyderabad/Bogota

• % of travel expected: Travel required as per business need

• Job type: Permanent and Full time

About the job    

Our Team:

Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.

The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.

Main responsibilities:

The Clinical Project Leader (CPL) is responsible and accountable for start-up and follow up on Registries in close collaboration with Registry Team and Medical Affairs staff in the countries or locally. The CPL has responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures (SOP), and local regulatory guidelines.

Feasibility Activities:

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

Study Start-up Activities:

• 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.

Project Management:

• 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).

Safety & Quality:

• 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.

Study administration:

• 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:

  • 5+ years of experience in Clinical research & development including at least 2 years in clinical trial project management experiences.

  • Project management certification preferred.

  • Strong quantitative, analytical (technical and business) and problem-solving skills is a must.

  • Excellent cross-functional collaboration skill and experience required.

  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.

  • Management, leadership, negotiation skills and analytical, and planning abilities.

  • Results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues, reactivity to emergent needs, able to prioritize, time management.

  • Experience in working in global projects and international matrix environment.

• Soft skills:

  • Excellent written and oral communication skills.

  • Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.

  • Demonstrated ability and sensitivity in working across countries that may have different business cultures.

• Technical skills:

  • Good understanding of the principles of ICH-GCP and applicable local regulatory requirements.

  • Familiarity with CTMS is essential for planning, tracking, and managing registries activities.

  • Proficiency in EDC systems is crucial for collecting, managing, and analyzing registries data.

  • Understanding FDA regulations, ICH/GCP guidelines, and other regulatory requirements is vital to ensure compliance throughout the trial.

  • Skills in data management, including data cleaning, validation are important for ensuring the integrity and accuracy of registries data.

  • Ability to identify, assess, and mitigate risks associated with registries to ensure smooth project execution.

  • Take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress.

  • Embrace change and innovation by supporting the evolution of the Registry study function, driving improved effectiveness.

  • Competent with Microsoft Office products.

• 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.

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