Clinical Trials Manager II

• Must meet all requirements for Principal Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
• In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Coaches members of a work team and ensures adherence to established guidelines.
• Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
• Anticipates obstacles and client difficulties and implements solutions to achieve project goals.
• Assists CPM in revising project timelines/budgets as necessary.
• Works with management on departmental issues, providing input to clinical operations strategies and work plans.
• Communicates with functional peers regarding project status and issues and ensure project team goals are met. Contributes to development of abstracts, presentations and manuscripts.
• Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.
• Participate in training of CPAs and CRAs. Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
• Excellent interpersonal skills and demonstrated ability to lead is required.

• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Ability to examine functional issues from a broader organizational perspective.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (650)-399-0891

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