Job Description
The Director, Clinical Operations is responsible for the implementation and management of clinical studies, from phase 1 to phase 4, and potentially in more than one therapeutic area. Additionally, this position is responsible for assisting in meeting functional, organizational and corporate goals.
Responsibilities
Leads one or more clinical studies, from concept to protocol, and through the achievement of corporate objectives such as First Patient In, Interim Analysis, etc.
Leads the development of protocol and study documents, e.g. consent templates, site reference manuals, monitoring plan, pharmacy manual.
Oversee and/or prepares materials and provides study training, e.g. initial regulatory document “IP Release” package for sites, investigator meetings, vendor kickoff meetings, site initiation visits, ad hoc internal or external training.
Leads inspection-readiness activities for sites and the internal groups involved in clinical trial conduct. Responsible for preparation and training of sites and Clinical Operations team in the event of GCP inspections, whether performed by QA or regulatory agency.
Leads the assessment and selection of Contract Research Organizations (CROs), sites, and other vendors; may perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.
Assists with national agency (FDA, Competent Authority) and local IRB and Ethics Committee submissions and subsequent responses.
Responsible for oversight of CROs and/or site monitors, sites and other vendors, ensures compliance with GCP/ICH, monitoring plan, protocol, and Scope of Work; initiates corrective and preventive action plans with as necessary.
Participates in the development of study-specific Case Report Forms, user testing and implementation of the clinical database and associated edit checks, and development of associated documents (e.g. CRF completion guidelines, site training materials).
Leads the data review process to ensure data accuracy and achievement of planned milestones such as database lock; works closely with other internal/external functional groups including Pharmacovigilance, Clinical Data Management, Clinical Sciences, Biostatistics and Medical Writing.
Oversees Trial Master File and Clinical Trial Management System (CTMS) for assigned trials/programs; responsible for reconciliation of the TMF when transferred from an external vendor.
Responsible for internal study-related reporting, communications and collaboration with other departments and vendors/consultants, including Regulatory Affairs, Quality Assurance, Clinical Drug Supply and Pharmacovigilance.
Develops site budget templates, negotiation of budget with sites, and facilitation of site clinical trial agreement negotiations.
Oversees the tracking and administration of investigator payments.
For assigned studies, develops and maintains a project management plan which tracks key study and program milestones, detailed enrollment tracking and contingency plans, and budget/resource assessment.
MS Project experience required.
May review clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory submissions (i.e. IND annual reports, annual or periodic safety reports, IND and NDA filings) for accuracy, consistency and quality.
May be responsible for the supervision, management and mentoring of internal and/or contracted Clinical Operations staff members (e.g. Clinical Project Managers, CRAs, CRA Assistants).
Develops and/or reviews Clinical Operations SOPs and departmental policies.
Lead and/or represent functional group in internal and external cross-functional teams.
May be responsible for and/or assist with departmental resource assessments, forecasting and management.
May develop and/or assist with the development of departmental and corporate initiatives that further efficiencies and/or improve overall organization value.
May represent the organization at scientific and/or industry meetings.
Desired Skills and Experience
Requirements
Bachelor’s degree in a biological science is strongly preferred. Requires at least 10 years of clinical development experience (at least five years managing clinical research projects and managing clinical research teams). Must have vendor management experience in clinical development, with pediatric, orphan drug and/or rare disease knowledge very helpful. Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary. Must be able and willing to travel on a periodic basis.Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook).
The Director, Clinical Operations is responsible for the implementation and management of clinical studies, from phase 1 to phase 4, and potentially in more than one therapeutic area. Additionally, this position is responsible for assisting in meeting functional, organizational and corporate goals.
Responsibilities
Leads one or more clinical studies, from concept to protocol, and through the achievement of corporate objectives such as First Patient In, Interim Analysis, etc.
Leads the development of protocol and study documents, e.g. consent templates, site reference manuals, monitoring plan, pharmacy manual.
Oversee and/or prepares materials and provides study training, e.g. initial regulatory document “IP Release” package for sites, investigator meetings, vendor kickoff meetings, site initiation visits, ad hoc internal or external training.
Leads inspection-readiness activities for sites and the internal groups involved in clinical trial conduct. Responsible for preparation and training of sites and Clinical Operations team in the event of GCP inspections, whether performed by QA or regulatory agency.
Leads the assessment and selection of Contract Research Organizations (CROs), sites, and other vendors; may perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.
Assists with national agency (FDA, Competent Authority) and local IRB and Ethics Committee submissions and subsequent responses.
Responsible for oversight of CROs and/or site monitors, sites and other vendors, ensures compliance with GCP/ICH, monitoring plan, protocol, and Scope of Work; initiates corrective and preventive action plans with as necessary.
Participates in the development of study-specific Case Report Forms, user testing and implementation of the clinical database and associated edit checks, and development of associated documents (e.g. CRF completion guidelines, site training materials).
Leads the data review process to ensure data accuracy and achievement of planned milestones such as database lock; works closely with other internal/external functional groups including Pharmacovigilance, Clinical Data Management, Clinical Sciences, Biostatistics and Medical Writing.
Oversees Trial Master File and Clinical Trial Management System (CTMS) for assigned trials/programs; responsible for reconciliation of the TMF when transferred from an external vendor.
Responsible for internal study-related reporting, communications and collaboration with other departments and vendors/consultants, including Regulatory Affairs, Quality Assurance, Clinical Drug Supply and Pharmacovigilance.
Develops site budget templates, negotiation of budget with sites, and facilitation of site clinical trial agreement negotiations.
Oversees the tracking and administration of investigator payments.
For assigned studies, develops and maintains a project management plan which tracks key study and program milestones, detailed enrollment tracking and contingency plans, and budget/resource assessment.
MS Project experience required.
May review clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory submissions (i.e. IND annual reports, annual or periodic safety reports, IND and NDA filings) for accuracy, consistency and quality.
May be responsible for the supervision, management and mentoring of internal and/or contracted Clinical Operations staff members (e.g. Clinical Project Managers, CRAs, CRA Assistants).
Develops and/or reviews Clinical Operations SOPs and departmental policies.
Lead and/or represent functional group in internal and external cross-functional teams.
May be responsible for and/or assist with departmental resource assessments, forecasting and management.
May develop and/or assist with the development of departmental and corporate initiatives that further efficiencies and/or improve overall organization value.
May represent the organization at scientific and/or industry meetings.
Desired Skills and Experience
Requirements
Bachelor’s degree in a biological science is strongly preferred. Requires at least 10 years of clinical development experience (at least five years managing clinical research projects and managing clinical research teams). Must have vendor management experience in clinical development, with pediatric, orphan drug and/or rare disease knowledge very helpful. Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary. Must be able and willing to travel on a periodic basis.Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook).
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