[Hiring] Manager, Clinical Trial Operations @Smart IMS

Role Description

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.
• 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.
• 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.
• Collaborates with regional MSLs (if applicable) to support investigator engagement activities.
• 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.
• Develops and manages detailed project and other trial-related plans.
• 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.
• Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with COL/Sr. CTM.
• 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.
• Supports inspection readiness preparation and maintenance throughout the life cycle of the trial.

Qualifications

• Bachelor's degree preferred in the life sciences, healthcare, or related.
• Minimum of 5+ years of clinical trial management experience within pharmaceutical/biotechnology industry.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing large and/or complex studies and project teams is preferred.
• Demonstrated experience managing CROs and other specialty vendors.
• 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 environments.
• 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 skills.
• Must successfully exhibit five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity.

Requirements

• The hourly range for roles of this nature are $90.00 to $100.00/hr.
• Rates are heavily dependent on skills, experience, location, and industry.

Company Description

cyberThink is an Equal Opportunity Employer.