Cedent Consulting Inc
Director/Senior Director, Clinical Operations (Boston, MA)
Cedent Consulting Inc, Boston, Massachusetts, us, 02298
Director/Senior Director, Clinical Operations (Boston, MA)
Summary:As the Head of Clinical Operations, you will lead the clinical operations strategy and oversee clinical studies, driving industry-leading execution speed and quality. As a key functional leader and subject matter expert, you will collaborate with cross-functional program teams to achieve departmental and corporate goals.Responsibilities:Lead strategic planning and daily study operations, focusing on site oversight from startup to closeout, patient enrollment, monitoring, compliance, and data flow with clinical sites, CROs, and vendors.Develop and implement global operations strategies with Clinical Development to optimize timelines while ensuring high quality and integrity.Collaborate with cross-functional teams to deliver clinical studies on time and within budget, ensuring quality in line with protocols, ICH GCP, regulatory guidelines, and patient safety.Manage clinical CROs, acting as the primary contact to identify and resolve issues, ensuring adherence to agreements, timelines, and quality standards.Build and maintain strong relationships with global investigators, clinical site staff, and vendors.Generate reports to communicate study progress and key metrics to Leadership and program teams.Partner with Finance and vendors to maintain accurate budgets and cost tracking for each clinical study.Contribute to preparation and review of key study documents, including protocols, informed consent forms, case report forms, and clinical study reports.Oversee the collection and analysis of clinical trial data, ensuring data accuracy and integrity.Participate in creating and updating clinical operations SOPs and coordinate with Quality Assurance for site and vendor audits.Hire, train, and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.Requirements:BA/BS in a scientific discipline, with 10-12+ years of experience in clinical operations within pharma or biotech (experience with small to medium-sized companies preferred).Broad knowledge of biopharmaceutical drug development, including ICH and GCP guidelines and regulations.Preferred experience in immunology/inflammation clinical development.Strong experience managing collaborations with CROs, vendors, and external organizations, with experience in global clinical trial implementation.Excellent interpersonal skills and ability to build relationships with key stakeholders, along with conflict management and negotiation skills.Proactive mindset with strong leadership, teamwork, influence management, organizational skills, and the ability to work independently.Proficiency in project management practices, project planning, goal setting, prioritization, and time management.Ability to thrive in a dynamic, fast-paced biotech environment.Willingness to travel as required.This is a full time position.
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Summary:As the Head of Clinical Operations, you will lead the clinical operations strategy and oversee clinical studies, driving industry-leading execution speed and quality. As a key functional leader and subject matter expert, you will collaborate with cross-functional program teams to achieve departmental and corporate goals.Responsibilities:Lead strategic planning and daily study operations, focusing on site oversight from startup to closeout, patient enrollment, monitoring, compliance, and data flow with clinical sites, CROs, and vendors.Develop and implement global operations strategies with Clinical Development to optimize timelines while ensuring high quality and integrity.Collaborate with cross-functional teams to deliver clinical studies on time and within budget, ensuring quality in line with protocols, ICH GCP, regulatory guidelines, and patient safety.Manage clinical CROs, acting as the primary contact to identify and resolve issues, ensuring adherence to agreements, timelines, and quality standards.Build and maintain strong relationships with global investigators, clinical site staff, and vendors.Generate reports to communicate study progress and key metrics to Leadership and program teams.Partner with Finance and vendors to maintain accurate budgets and cost tracking for each clinical study.Contribute to preparation and review of key study documents, including protocols, informed consent forms, case report forms, and clinical study reports.Oversee the collection and analysis of clinical trial data, ensuring data accuracy and integrity.Participate in creating and updating clinical operations SOPs and coordinate with Quality Assurance for site and vendor audits.Hire, train, and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.Requirements:BA/BS in a scientific discipline, with 10-12+ years of experience in clinical operations within pharma or biotech (experience with small to medium-sized companies preferred).Broad knowledge of biopharmaceutical drug development, including ICH and GCP guidelines and regulations.Preferred experience in immunology/inflammation clinical development.Strong experience managing collaborations with CROs, vendors, and external organizations, with experience in global clinical trial implementation.Excellent interpersonal skills and ability to build relationships with key stakeholders, along with conflict management and negotiation skills.Proactive mindset with strong leadership, teamwork, influence management, organizational skills, and the ability to work independently.Proficiency in project management practices, project planning, goal setting, prioritization, and time management.Ability to thrive in a dynamic, fast-paced biotech environment.Willingness to travel as required.This is a full time position.
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