Clinical Research Scientist / Project Coordinator / Manager / CRA

Role & responsibilities

1. Contributing to all aspects of clinical trial projects, from concepts to close out stages.

2. Developing & implementing clinical trial project plans; Plan & track project timelines, key milestones & deliverables.

3. Contribute to development, review, and approval of protocols, eCRF, study documents, and reports.

4. Managing resources to ensure compliance with regulations, timelines and budgets.

5. Managing interface with all stakeholders including study sponsors, investigators, ethics committees, regulatory authorities & vendors.

6. Providing operational insights for compliance with regulations, protocol, SOPs, policies and practices.

7. Identify & monitor risks throughout the project lifecycle and facilitate plans for risk mitigation.

8. Contribute to development & evolution of operational generic or project-specific SOPs and ensure compliance.

9. Identify training requirements for internal team, site staff, vendors, and other stakeholders, and facilitate trainings.

10. Maintaining all project documents including TMF.

Preferred candidate profile

1. 5+ years of experience in clinical research operations, preferably around global clinical trials, with at least 2+ years of experience in managing clinical trial projects

2. A degree in medicine, pharmacy, or life sciences.

3. In-depth understanding of GCP, clinical trial regulations and contemporary industry practices

4. An attitude to aim for excellence, and a firm commitment to compliance

5. Outstanding communication, time management, strategic thinking, negotiation, and problem-solving skills

6. Experience in managing a multifunctional clinical trial management team

7. Ability to organize and prioritize workload & taking initiative

8. A high level of proficiency in using MS Office