Convatec
About the Role
This is a remote US‐Based role for a Senior Clinical Study Manager – Device at Convatec. The position resides in the Eastern Time Zone and requires a strong clinical study lifecycle background. Key Responsibilities
Proactively manage assigned clinical studies from start‑up through closeout. Coordinate clinical study team activities, deliver milestones, and lead issue resolution with limited oversight. Identify and mitigate study risks, manage study finance tracking, and provide progress reports. Oversee the production of core study documentation including CIP, IB, ICF, and CSR. Support audit and inspection activities and update SOPs to enhance quality by design. Build relationships with cross‑functional teams such as Medical Affairs and Medical Writing. May be assigned additional responsibilities as needed. Skills & Experience
Strong knowledge of the clinical study lifecycle and device experience. Experience managing study timelines, budgets, and resources. Advanced knowledge of GCP and federal regulations governing clinical research. Excellent collaborative team player with attention to detail. Experience with pre‑market (IDE) and post‑market device clinical studies and Clinical Trial Management Systems. Qualifications & Education
Bachelor’s or Master’s degree in life sciences, medicine, or related discipline. Minimum 10 years of clinical research experience, including 5 years in clinical study management. Travel & Working Conditions
Remote working with occasional travel up to 20% of the time, primarily domestic but may include international travel and overnight stays. Languages
English – speaking and written proficiency required. Equal Opportunity
Convatec provides equal employment opportunities for all employees and applicants. No discrimination on any protected basis. Convatec is not accepting unsolicited resumes from agencies or search firms for this position.
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This is a remote US‐Based role for a Senior Clinical Study Manager – Device at Convatec. The position resides in the Eastern Time Zone and requires a strong clinical study lifecycle background. Key Responsibilities
Proactively manage assigned clinical studies from start‑up through closeout. Coordinate clinical study team activities, deliver milestones, and lead issue resolution with limited oversight. Identify and mitigate study risks, manage study finance tracking, and provide progress reports. Oversee the production of core study documentation including CIP, IB, ICF, and CSR. Support audit and inspection activities and update SOPs to enhance quality by design. Build relationships with cross‑functional teams such as Medical Affairs and Medical Writing. May be assigned additional responsibilities as needed. Skills & Experience
Strong knowledge of the clinical study lifecycle and device experience. Experience managing study timelines, budgets, and resources. Advanced knowledge of GCP and federal regulations governing clinical research. Excellent collaborative team player with attention to detail. Experience with pre‑market (IDE) and post‑market device clinical studies and Clinical Trial Management Systems. Qualifications & Education
Bachelor’s or Master’s degree in life sciences, medicine, or related discipline. Minimum 10 years of clinical research experience, including 5 years in clinical study management. Travel & Working Conditions
Remote working with occasional travel up to 20% of the time, primarily domestic but may include international travel and overnight stays. Languages
English – speaking and written proficiency required. Equal Opportunity
Convatec provides equal employment opportunities for all employees and applicants. No discrimination on any protected basis. Convatec is not accepting unsolicited resumes from agencies or search firms for this position.
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