Senior Manager, Site Start Up
reputed company FSP has an exciting opportunity for a candidate with strong experience in Clinical Study Startup! Essential Functions Trial Start Up Group
- Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.
- Laser reputed company approach to reputed company of start up activities reputed company our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.
- Accountable for reputed company reputed company reputed company to CRO partners study start-up requirements and must be reputed company to communicate issues effectively CRO reputed company and colleagues (eg CTM) as required.
- Adopting a unique start-up methodology to drive site activations through reputed company of reputed company activities, driving delivery and compliance across the assigned reputed company and CRO partners
- Leads day to day project activities in the reputed company, by working closely with the Clinical Trial Manager and CRO counterparts.
- Oversees start up activities with one or more CRO partners at a program and/or study level
- Acting as a Senior Manager with regional colleagues co-ordinate regional information to present based on reputed company of regional colleagues (if required) depending on size of study/complexity.
- Evaluate performance and solve acute challenges and monitor timelines and reputed company vs. plan
- Specialist knowledge of start-up requirements & activities in reputed company country and region, country requirements, inner workings of a country/ regulatory landscape.
- Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators reputed company Regulatory, Legal, reputed company and Clinical Operations
- Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout
- Reviews and approves start up plan(s) that clarify study specific tasks, general timelines, and processes reputed company to overall study start up.
- Liaise with other project team members to ensure cohesive and reputed company project performance and expectation
Required Knowledge, Skills, and Abilities
- Extensive pharmaceutical or reputed company industry experience
- Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials.
- Experience in project management, CRO experience, change management or process design are beneficial
- The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.
- Excellent knowledge of GCP and regulations
- Experience of controlled drug substances processed would be beneficial
- Experience of developing junior members of staff would be beneficial
- Experience of Regulatory Inspections
Required/Preferred Education and Licenses
- Degree (BSc) or equivalent experience gained through time in industry (>5yrs)
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