Clinical Trial Manager - Phase 1 Studies

SRG, the leader in the Life Sciences human capital industry, is looking for a Clinical Trial Manager - Phase 1 Studies to join our team in Waltham, Mass.

The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development. He/She will lead operations across all future clinical sites to ensure operational and the organization's objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.

Onsite/Hybris: Waltham, Mass (onsite 3 days per week)

Contract: 7 months

Qualifications & Skills:

• S or Ph.D in basic sciences with 10 years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO.
• Phase I trial experience
• Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience leading global trials - outside the US/UE/ASIA/Americas is preferred.
• Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
• Demonstrated experience in successful planning and implementation of clinical trial operations.
• Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.

Responsibilities:

• Responsible for developing strategy, and methodology of clinical operations programs.
• Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
• Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals.
• Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines.
• Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
• Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols.
  

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.