Genabio Diagnostics
Clinical Operations Manager (Contracted Role – 6 Months)
Genabio Diagnostics, Boston, Massachusetts, us, 02298
Clinical Operations Manager (Contracted Role – 6 Months)
The Clinical Operations Manager (Contract) is responsible for planning, coordinating, and executing clinical trial activities to ensure compliance with regulatory, ethical, and company requirements. This hands‑on role covers site management, TMF organization, study documentation, and data oversight to ensure successful and timely study delivery.
Responsibilities
Clinical Study Planning & Documentation: Develop, review, and manage essential clinical trial documents, including protocols, informed consent forms, investigator brochures, monitoring plans, and CRFs. Organize, maintain, and ensure ongoing quality of the Trial Master File (TMF) in compliance with GCP and company SOPs. Support development of study timelines, milestones, and operational plans.
Site Management: Identify and qualify clinical trial sites in collaboration with internal teams and investigators. Manage site feasibility and qualification visits, maintain ongoing communication with study sites, oversee IRB/EC submissions and track approvals and renewals.
Study Preparation: Prepare and coordinate site initiation activities, including investigator and coordinator training. Develop and distribute study materials (e.g., investigator site files, lab kits, binders, and study‑specific tools).
Study Conduct: Conduct site initiation, monitoring, and close‑out visits (SIV, IMV, COV) in accordance with ICH‑GCP, ISO 14155, and study‑specific requirements. Ensure monitoring activities are conducted per GCP, protocol, and SOPs. Manage issue tracking, deviation management, and corrective/preventive actions.
Data Management: Manage and maintain Electronic Data Capture (EDC) systems, ensuring accurate data verification and validation. Coordinate data review and query resolution with data management and biostatistics teams.
Timeline & Quality Management: Track study progress against agreed timelines and deliverables. Ensure all trial activities comply with ICH‑GCP, ISO 14155, and relevant regulatory requirements. Support audit readiness, TMF inspection preparation, and regulatory submissions.
Qualifications & Requirements
Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
Minimum 5 years of experience in clinical research or clinical operations, preferably in medical device or IVD trials.
Strong knowledge of ICH‑GC, ISO 14155, and clinical study regulatory requirements.
Proven experience in TMF organization and maintenance throughout the study lifecycle.
Hands‑on experience conducting site monitoring visits (SIV, IMV, COV) and managing study documentation.
Strong organizational, problem‑solving, and communication skills.
Ability to manage multiple projects and work independently under minimal supervision.
Experience in managing vendors and CROs is an advantage.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Medical Equipment Manufacturing and Biotechnology Research
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Responsibilities
Clinical Study Planning & Documentation: Develop, review, and manage essential clinical trial documents, including protocols, informed consent forms, investigator brochures, monitoring plans, and CRFs. Organize, maintain, and ensure ongoing quality of the Trial Master File (TMF) in compliance with GCP and company SOPs. Support development of study timelines, milestones, and operational plans.
Site Management: Identify and qualify clinical trial sites in collaboration with internal teams and investigators. Manage site feasibility and qualification visits, maintain ongoing communication with study sites, oversee IRB/EC submissions and track approvals and renewals.
Study Preparation: Prepare and coordinate site initiation activities, including investigator and coordinator training. Develop and distribute study materials (e.g., investigator site files, lab kits, binders, and study‑specific tools).
Study Conduct: Conduct site initiation, monitoring, and close‑out visits (SIV, IMV, COV) in accordance with ICH‑GCP, ISO 14155, and study‑specific requirements. Ensure monitoring activities are conducted per GCP, protocol, and SOPs. Manage issue tracking, deviation management, and corrective/preventive actions.
Data Management: Manage and maintain Electronic Data Capture (EDC) systems, ensuring accurate data verification and validation. Coordinate data review and query resolution with data management and biostatistics teams.
Timeline & Quality Management: Track study progress against agreed timelines and deliverables. Ensure all trial activities comply with ICH‑GCP, ISO 14155, and relevant regulatory requirements. Support audit readiness, TMF inspection preparation, and regulatory submissions.
Qualifications & Requirements
Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
Minimum 5 years of experience in clinical research or clinical operations, preferably in medical device or IVD trials.
Strong knowledge of ICH‑GC, ISO 14155, and clinical study regulatory requirements.
Proven experience in TMF organization and maintenance throughout the study lifecycle.
Hands‑on experience conducting site monitoring visits (SIV, IMV, COV) and managing study documentation.
Strong organizational, problem‑solving, and communication skills.
Ability to manage multiple projects and work independently under minimal supervision.
Experience in managing vendors and CROs is an advantage.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Medical Equipment Manufacturing and Biotechnology Research
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