Advanced Recruiting Partners
Clinical Trial Manager
Advanced Recruiting Partners, Raleigh, North Carolina, United States, 27601
Clinical Trial Manager
Lead and manage operational aspects of global clinical trials from study start‑up through close‑out.
Oversee study timelines, deliverables, and budgets to ensure milestones are met.
Coordinate with cross‑functional teams, external vendors, and CROs to ensure high‑quality study conduct.
Oversee site activation, clinical monitoring, data integrity, and adherence to protocol.
Conduct study‑level risk assessments and ensure inspection readiness.
Manage safety and pharmacovigilance activities in collaboration with internal and external teams.
Lead internal and external study meetings; provide training to relevant stakeholders.
Contribute to the development of study‑related documents and clinical study reports.
Perform other duties as needed to support successful trial execution.
Qualifications
Bachelor’s degree in life sciences or a related field (advanced degree preferred).
Minimum of 8 years of clinical trial management experience, particularly in
respiratory trials or pediatric studies .
Demonstrated success in leading global trials and working with cross‑functional and vendor teams.
Deep understanding of GCP, ICH guidelines, and global regulatory requirements.
Specific therapeutic experience in respiratory diseases, strongly preferred.
Strong project management, problem‑solving, and communication skills.
Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel.
Seniority Level Associate
Employment Type Full‑time
Job Function Science
#J-18808-Ljbffr
Lead and manage operational aspects of global clinical trials from study start‑up through close‑out.
Oversee study timelines, deliverables, and budgets to ensure milestones are met.
Coordinate with cross‑functional teams, external vendors, and CROs to ensure high‑quality study conduct.
Oversee site activation, clinical monitoring, data integrity, and adherence to protocol.
Conduct study‑level risk assessments and ensure inspection readiness.
Manage safety and pharmacovigilance activities in collaboration with internal and external teams.
Lead internal and external study meetings; provide training to relevant stakeholders.
Contribute to the development of study‑related documents and clinical study reports.
Perform other duties as needed to support successful trial execution.
Qualifications
Bachelor’s degree in life sciences or a related field (advanced degree preferred).
Minimum of 8 years of clinical trial management experience, particularly in
respiratory trials or pediatric studies .
Demonstrated success in leading global trials and working with cross‑functional and vendor teams.
Deep understanding of GCP, ICH guidelines, and global regulatory requirements.
Specific therapeutic experience in respiratory diseases, strongly preferred.
Strong project management, problem‑solving, and communication skills.
Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel.
Seniority Level Associate
Employment Type Full‑time
Job Function Science
#J-18808-Ljbffr