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).

• 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.

• 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)