Clinical Study Lead - Cardiovascular Outcomes (CVO)

Summary: The Clinical Study Lead for Cardiovascular Outcomes (CVO) is responsible for overseeing the execution of clinical studies, ensuring compliance with company SOPs and GCP. This role involves collaboration with various stakeholders, managing relationships with CROs, and ensuring timely delivery of study milestones. The position is based in London and is offered on a 6-month contract basis. The pay rate ranges from £650 to £700 per day via an umbrella agency.

Key Responsibilities:

• Accountable to ensure all relevant studies follow company SOPs and GCP.
• With direction, may matrix with key Study conduct partners.
• Assist with maintaining relationships and monitor performance of CRO's and other vendors.
• With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, and Operations Management) to ensure on time delivery of studies.
• Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
• With oversight manage study start-up, conduct and close-out.
• Manage clinical trial material.
• Assist in the management of CRO's or other outsourcing partners as appropriate.
• Provide input into content and execution of investigator meetings / may present selected topics.
• Provide input into development of CRF.
• Provide input into site selection with coordinated input.

Key Skills:

• Experience in study delivery role (study leader or study manager) on cardiovascular outcomes study/ies (CVO)
• Managing complex global study footprints
• Oversight of high site volumes (100-1,000+ sites)
• Leading cross-functional study teams
• Experience with Clinical Endpoint Committees (CEC)
• Leading large, geographically dispersed teams
• Scientific understanding (cardiovascular endpoints & populations)
• Operational expertise (large, global, long-term trials)
• Analytical skills (event-driven monitoring, data interpretation)
• Leadership & communication (alignment across complex stakeholder networks)
• Familiarity with: Data Monitoring Committees (DMC/DSMB)

Salary (Rate): £700 per day

City: London

Country: England

Working Arrangements: undetermined

IR35 Status: inside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Clinical Study Lead - Cardiovascular Outcomes (CVO)
Clinical Study Lead - Cardiovascular Outcomes (CVO)

The location of the role is London.
The duration of the contract is 6 months.
The pay rate on offer is £650 - £700 per day (via Umbrella agency).

Key accountabilities of the role

• Accountable to ensure all relevant studies follow company SOPs and GCP.
• With direction, may matrix with key Study conduct partners.
• Assist with maintaining relationships and monitor performance of CRO's and other vendors.
• With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, and Operations Management) to ensure on time delivery of studies.
• Provide input into identifying implications of study progress upon overall timeline goals conduct plans.
• With oversight manage study start-up, conduct and close-out.
• manage clinical trial material.
• Assist in the management of CRO's or other outsourcing partners as appropriate.
• Provide input into content and execution of investigator meetings / may present selected topics.
• Provide input into development of CRF.
• Provide input into site selection with coordinated input.

Key skills and experience

• Experience in study delivery role (study leader or study manager) on cardiovascular outcomes study/ies (CVO)
• Managing complex global study footprints
• Oversight of high site volumes (100-1,000+ sites)
• Leading cross-functional study teams
• Experience with Clinical Endpoint Committees (CEC)
• Leading large, geographically dispersed teams
• Scientific understanding (cardiovascular endpoints & populations)
• Operational expertise (large, global, long-term trials)
• Analytical skills (event-driven monitoring, data interpretation)
• Leadership & communication (alignment across complex stakeholder networks)
• Familiarity with: Data Monitoring Committees (DMC/DSMB)