Clinical Trial Business Operations - Manager

• Supports the Clinical Operations Lead (COL)and/or Senior Clinical Trial Manager (Sr. CTM) with management and execution of all clinical trial activities in compliance with GCP and relevant regulatory
• Detailed management and oversight of regional trial activities, as
• Supports Clinical Operations Lead and/or Senior Clinical Trial Manager with coordination of cross-functional clinical study team activities to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management plann
• Manages regional monitoring oversight of site-level activities related to ongoing and planned trials as assigned.
• Supports development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites.
• Participates in the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials.
• Creates and/or reviews and approves specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans. Liaises with CRO and legal to provide language acceptable for IRB’s/EC’s.
• Participates in site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets.
• Collaborates with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences.
• Participates in Risk-Based Quality Management (RBQM) activities to ensure data integrity and patient safety.
• Implements risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials.
• Develops and manages detailed project and other trial-related plans and
• Supports the COL and/or Sr. CTM with planning of and may attend investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings as requested.
• May attend site visits for CRO oversight and/or investigator engagement.
• Supports the COL and/or Sr. CTM with oversight of CRO/vendor performance through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
• Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope (eg, cost, timelines) and collaborating with COL/Sr. CTM to ensure timely completion of contractual documents, including change

Data Review

• Collaborates closely with Data Management and other functional areas, vendors, and the CRO to achieve database lock milestones during the project lifecycle.
• May work collaboratively with Clinical Scientist, Clinical Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.

Inspection Readiness

• Supports inspection readiness preparation and maintenance throughout the life-cycle of the trial, including but not limited to ensuring Trial Master File documents are appropriately filed, and reconciled at end of the study.

Skills

• Minimum of 5+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial
• Experience in rare disease and/or orphan indications is
• Experience managing large and/or complex studies and project teams is preferred.
• Demonstrated experience managing CROs and other specialty vendors is
• Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
• Demonstrated strong leadership skills and the ability to work successfully in matrixed team environme
• Can work independently with limited oversight and proactively initiates before asked to assist colleagues and/or manager
• Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation
• Excellent written and oral communication skills, as well as conflict management, time management and organizational skill
• Must successfully exhibit the companies five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.

Education

Bachelor's degree preferred in the life sciences, healthcare, or related

Pay Range: $90-100/hr *based on experience