Clinical Project lead

KEY RESPONSIBILITIES AND DUTIES:

Project Management:

• Selection of Investigators.
• Prepares protocol and other study documents.
• Plans submissions to regulatory authorities and ethics committees.
• Implement clinical research activities relating to pre-study, initiation, monitoring, site termination and post study activities.
• Documents, tracks and reports all study events according to SOPs and Project teams’ requirements.
• Manages/tracks all study/project related finances.
• Trains in-house and on-site personnel in relation to the study.
• Ensures the good follow-up of the centers, notably by: conducting co-monitoring visits evaluating monitoring reports, tracking recruitment.

Project Accountability:

• Manages all clinical trials / studies activities relating to pre-study, initiation, monitoring, site termination and post study activities according to SOP’s.
• Ensures clinical trials / studies are conducted in compliance with the agreed patient target, timelines and quality standards by co-monitoring, assessing monitoring reports, following the recruitment and regular discussions with project teams.
• Ensure clinical studies are conducted in compliance with SOP’s, regulatory requirements, and international GCP standards.
• Arrange and assist with regular in-house staff training
• Implement, maintain and encourage updating of training files

Ensure effective use of resources and appropriate tools by:

• Managing budget
• Project planning
• Achieve patient inclusion targets and timelines

Establish a high performing clinical operation team by recruiting and developing people within the appropriate working environment

• Develop and Update Local SOPs
• Training, coaching and motivating
• Conducts Performance Evaluation process for his/her team Begin/Mid/End year process within the communicated deadline ensuring 100% completion of his/her team
• Identify personal & staff development needs

Contribute to the local business plan by fostering interactions with internal and external bodies

• Brand teams
• Regulatory
• Medical management team
• International Clinical Research Unit
• Key External Expert

People Management:

• Manages a team of contracted CRAs.
• Ensures adequately knowledgeable and efficient operating team.
• Ensures efficient utilization of resources.
• Conducts Performance Evaluation process for his/her team Begin/Mid/End year process within the communicated deadline ensuring 100% completion of his/her team.

Therapeutic Area Management:
Work across different therapeutic areas as required.

Quality Control:

• Ensures that the studies/registries carried out at highest levels within the global and local SOP’s.
• Facilitates preparation of CRAs/sites for internal site audits and may conduct random audits per protocol.
• Attends and assists with in-house staff training.

Financials

• Plan, Prepare and revise study/project budget/AEDs to ensure recovery of business unit expenditure
• Adherence to study budget expenditure

Others:

• Perform other duties as assigned.
• Respect of company’s values, code of ethics and social charter.
• Respect of personal data protection charter.
• Responsible for applying the HSE related requirements for the company in all related working procedures.