Clinical Trial Leader Job

CLINICAL TRIAL LEADER needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

TOP SKILLS YOU SHOULD POSSESS:

- Clinical Operations experience
- GCP and ICH
- Trial budget and negotiation

WHAT YOU'LL BE DOING:

- Plan, facilitate and lead the global multidisciplinary Clinical Trial Team (CTT)
- Provide direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
- Communicate protocol information including changes or amendments to countries
- Create and implement an operational trial plan with line function support and stake-holder management with tracking to plan and updating as required
- Execute an operational risk management plan highlighting potential risks and actions.
- Create and drive trial level timelines
- Ensure all trial deliverables are met (ie, budget) on time with quality
- Provide updates at relevant internal/external (as applicable) boards
- Prepare all relevant study related documents required for trial initiation with Clinical Scientist (CS)/Medical Lead and line functions to ensure availability of high quality deliverables within specified timelines
- Accountable to write monitoring plan (including any tools and forms) and ensure CSM and medical input
- Plan, drive and facilitate multi-national investigator meetings or equivalent investigator training.
- Management of vendor start up, development of data specifications, and oversight of vendor activities and interactions during the trial, including CRO and alliance partners.
- Collaborate with drug supply managers to ensure all aspects of the test article are man-aged throughout the trial.
- Manage overall trial conduct to trial close out in coordination with line functions and coun-tries
- Facilitate trial close out activities

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS in Life Science/Healthcare
- Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process.
- Demonstrated ability to influence without authority
- Project Management experience preferred
- 3 years technical and operational experience in planning/executing/reporting clinical trials
- Excellent negotiation and conflict resolution skills
- Ability to collaborate across partner functions in a Matrix environment
- Reproducible results in clinical operations
- Ability to work in a global cross-functional team
- Strong interpersonal skills
- Ability to work under pressure
- Resolve issues with supervision and understand when to escalate
- Demonstrated ability to effectively manage trial budget

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: SCIENTIFIC

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