• Ensure all activities under your management are conducted in accordance with project specific documentation, applicable SOPs, ICH GCP, and applicable regulatory requirements.

• Provide operational and logistical perspective in the development of the clinical strategy and clinical study planning by recommending solutions on specific deliverables.

• Identify project specific activities that need to be out-sourced and be involved in the selection of the suitable vendors.

• Implement and execute the clinical study plans for quality driven projects/trials including budget, timeline, including vendor management and oversight.

• Coordinate and drive project team to meet project specific deadlines.

• Assist in the development of project specific documents such as protocol, study manuals and ICFs as requested.

• Work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility questionnaire interview and /or site visit as applicable.

• Train vendors and sites on study protocol, procedures, and expectations.

• Maintain effective professional relationship with internal project team including Investigators and vendors.

• Review and sign-off monitoring visit reports if applicable.

• Track project scope and review/approve scope changes from vendors and approve invoices. .

• Track budget for Clinical Operations portion of project.

• Provide or contribute to progress reports for the management team and other stakeholders as applicable.

• Coordinate project administration e.g., organize project meetings, compile meeting notes or minutes and provide updates and follow-up actions discussed in meetings, prepare project newsletters

• Drive project team to deliver clean, accurate and verifiable data for interim and final analyses.

• TMF maintenance and verification throughout the project operation.

• A Bachelor’s degree in life sciences is required; An advanced degree is preferred (Master’s/PhD/PharmD/MD degree) Comprehensive knowledge of clinical trial processes.

• Rich experience of working on clinical projects within a CRO, biotech or pharmaceutical company environment. (at least 5 years above) including time in a leadership capacity.

• Experience supervising project related tasks of other functional groups or people.

• Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint, Project and Outlook and the Internet.

• Excellent working knowledge of, and ability to implement project activities in accordance with ICH-GCP and all applicable regulations and guidelines.

• Excellent interpersonal skills, presentation skills and team leadership ability.

• Ability to work well and flexibly i.e., autonomously, in small teams and with a wide range of varying stakeholders.

• Ability to see the big picture, yet still focus on detail.

• Ability to be flexible and adaptable in the face of changing organizational priorities.

• Ability to be flexible to participate in global calls outside normal business hours.

• Strong focus on quality of work.