Senior Clinical Study Manager or Clinical Study Manager

SUMMARY OF RESPONSIBILITIES:

Accountable for the clinical planning and conduct of clinical trial(s) and the management of clinical operation trial team(s) and/or sub-teams in-house or overseeing conduct by a clinical research organization (CRO). Responsible for clinical trial conduct including leading meetings, project planning, timelines, resource management, budget management, site management monitoring, vendor management, and project operational support in accordance with protocol, GCP regulations and ICH guidelines, and Standard Operating Procedures (SOPs). Shares best practices within Clinical, across trials and projects, contributing to process improvement initiatives. Performs assigned responsibilities to ensure timely completion of trial(s) and department goals and objectives with quality.

RESPONSIBILITIES:

• Leads operational strategy and conduct of clinical operations team(s) and/or sub-teams from trial start-up to closeout. Ensures conduct of clinical trial(s) in compliance with GCP/ICH regulations and guidelines, and applicable SOPs and Work Instructions.
• Manages and oversee activities related to the development and delivery of cross­ functional milestones: including but not limited to, development, review and/or maintenance of relevant trial plans (e.g., safety, monitoring, quality, communication, data management etc.) and trial manuals (pharmacy, labs, etc.). Collaborates with other trial team members to ensure consistency and efficiencies across the trial team, and other in­ house teams as assigned.
• Accountable for the development and management of the trial timelines and budget. Oversees, manages, tracks, and reports clinical trial budgets and development of staffing/resourcing plans. Identifies and develops metrics and operational tracking tools to support the operations team and for reporting to senior management on clinical trial conduct.
• Oversees cross-functional Protocol development, and review for operational feasibility, consistency, and compliance. Oversees development and approval of Informed Consent Form template. Participates in the generation of the Investigator Brochure (1B) and contribute, as needed, ensuring availability of 1B for trial conduct. Ensures regulatory approval of required documents for the conduct of the trial.
• Maintains oversight of and ensures consistency in the operational aspects of trial conduct, including involvement in daily management of Clinical Research Organization(s)-CROs/Vendors/Contractors.
• Oversees and track awareness and training on trial documents and process, current applicable regulations, rules, guidance and SOPs/Work Instructions across project(s).
• Develops and adjust sites and patient's enrollment strategy to support completion of trial on time and in compliance to regulatory guidance. Forecasts and manages clinical investigational product and clinical supplies.
• Performs routine reviews of key clinical data to identify trends, discrepancies, and errors, to ensure ongoing quality of conduct in accordance with the clinical development plan and applicable clinical trial protocol. Manages protocol deviation review - preventative action planning, immediate escalation of significant concerns to appropriate staff.
• Performs review and approval of site visit reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory and timely resolution of outstanding issues. Ensures consistency and quality of site monitoring visits, which may include conduct of periodic co-monitoring visits with monitoring Clinical Research Associate(s)-CRAs and/or training and supervision of co-monitors.
• Ensures communication of relevant trial information across trial personnel, timely communication of urgent information to the appropriate team members, and appropriate escalation of issues to trial team leadership.
• Develops, maintains and promotes positive, effective and collaborative working relationships with and among internal team members and as applicable, with external CRO and 3rd party vendor personnel and co-development partner trial teams.
• Identifies areas of best practice and process improvements, applying lessons learned with the trial and across projects, as applicable. Participates as requested, in the development and maintenance of SOPs and/or initiatives and departmental coaching/mentoring for the development of clinical personnel.

QUALIFICATIONS:

• Senior CSM: Master's degree (prefer nursing, health, or life sciences field) and a minimum of 6 years related experience, OR Bachelor's degree (similar fields) and a minimum of 8 years related experience
• CSM: Master's degree (prefer nursing, health, or life sciences field) and a minimum of 4 years related experience, OR Bachelor's degree (similar fields) and a minimum of 6 years related experience
• Experience in Hematology/ Oncology (preferably non-solid tumor) clinical trials is preferred
• 8 years of biopharmaceutical clinical research (preferred)

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:

• Teamwork, creativity, adaptability
• Effective written and verbal communication
• Proven leadership, decision-making, and deadline-oriented
• Ability to plan and organize, delegate, influence, and manage conflict
• Create and maintain department SOPs
• Coordinate and participate in Investigator Meetings
• Collaborate with department members to identify process optimization/best practices and lessons learned within clinical operations
• Proficient in Microsoft Office (Word, Excel, Power Point, and Project
• International Conference on Harmonization and Good Clinical Practice

TRAVEL REQUIREMENTS:

• Up to 25% as needed

PRECISION LIFE SCIENCES