Apex Life Sciences
: The Clinical Trial Manager will support ISS Operations by managing investigator-sponsored study operations and ongoing quality improvements in the processing and review of ISTs.
The CTM will liaise with field medical teams, medical units, legal, and other departments as needed to ensure investigator sponsored trial requirements are met or exceeded.
The CTM is responsible for driving the timely execution of contracts and financial payments, budgeting and financial forecasting, tracking of ISS study progression, management of the ISS database, and for maintaining ongoing metrics and reports on a regular basis.
Compliance with ISS SOPs, processes, systems and regulations and participation in improvement initiatives, taskforces, and committees to improve ISS processes. Additional responsibilities may be assigned based on level of experience and expertise.
Ability to educate others on ISS SOPs and processes, identify compliance issues and escalate accordingly to senior management.
Liaise directly with sponsor-investigators and ISS Review Committee members, including Medical Directors, Regional Medical Liaisons, Pharmacovigilance, Biostatistics, Legal/Regulatory and Clinical Supplies.
Actively participate in the review and evaluation of investigator-sponsored trial submissions for compliance with company policy and alignment with corporate strategy.
Track the execution of the ISTs and budgets from approval decisions through execution of contract payments, and outcomes.
Critically evaluate budgets for proposed ISTs, including accountability of accurate forecasting of ISS milestone payments.
Maintain an accurate and current database on the status of all ISTs.
Partner with Clinical Trial Associates in study management and conduct of ISS studies, including mentoring as appropriate.
Forecasting study drug requirements to Clinical Supplies and arranging for shipping and monitoring of study drug supply
Accountable for ISS records and history to be audit ready
Identifies when issues should be escalated to ISS Operations management and seeks input from appropriate team members.
Experience in managing budgets and forecasts, as relate to clinical trials
Demonstrated superb organizational, time management and communication skills (verbal and written)
Demonstrated experience working on multiple projects simultaneously
Strong interpersonal skills with the ability to interact with all levels of the organization
Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines
Exceptional project management, including managing multiple complex projects from start to completion
Demonstrated involvement in cross-functional clinical trial teams and capabilities in managing trial planning, initiation, executing, and reporting activities.
Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Bachelor Degree in business or science area with 4 years pharmaceutical/biotechnology industry experience in clinical research, clinical operations or medical affairs
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Apex Life Sciences