Parexel 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 focus approach to oversight of start up activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution. 

• ​Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively CRO counterpart and  colleagues (eg CTM) as required.  

• ​Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners 

• ​Leads day to day project activities in the matrix, 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 oversight of regional colleagues (if required) depending on size of study/complexity. 

• ​Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan 

• ​Specialist knowledge of start-up requirements & activities in each 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 within Regulatory, Legal, Contracts 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 related to overall study start up. 

• ​Liaise with other project team members to ensure cohesive and clear project performance and expectation 

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​Required Knowledge, Skills, and Abilities  

• ​Extensive pharmaceutical or related 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 

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​Required/Preferred Education and Licenses 

• ​Degree (BSc) or equivalent experience gained through time in industry (>5yrs)​​​ 

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