Senior Clinical Trial Manager Job Description Template
Our company is looking for a Senior Clinical Trial Manager to join our team.
Responsibilities:
- Show passion and enthusiasm to inspire and lead;
- Proactively help Study Start up and vendor management and Clinical Execution including management of trial timeline, budget, resources and vendors;
- Ensure potential study risks are escalated to the attention of the ED, Clinical when appropriate;
- Participate in the planning of quality assurance activities and coordinate resolution of audit findings;
- Ensure all clinical trials are executed in compliance with national/international GCP guidelines/regulations and SOPs;
- Collaborate with appropriate functions in the selection of CROs and vendors;
- Implement approved clinical trial protocols and operational plans, which are consistent with strategic corporate goals;
- In collaboration with Sr. Director, oversee and manage study budget to ensure study and projects remain with contractual obligations;
- Ensure audit-ready condition of Clinical Trial Master Files associated with their studies;
- Accountable for ensuring the “right subjects” and “right data” to meet our contractual requirements;
- Identify changes in scope and support project leader in completion of the change control process;
- Deliver the project/program according to the quality management plan. Guide CRA’s and advise on critical specific study issues;
- Drive for high performance and efficiency of the clinical team to support financial success of the project;
- Proactively identify risks to study timelines and budgets and propose risk mitigation strategies/solutions;
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Requirements:
- Demonstrated proficiency in using systems and technology to achieve work objectives;
- Excellent communication and presentation skills, including good command of English language;
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues;
- Proven ability at analyzing data and information to derive conclusions and drive sound decision making;
- Broad protocol knowledge; therapeutic knowledge;
- Good understanding of other company functions and their inter-relationship to achieve project delivery;
- Good understanding of project financials;
- Regular sitting for extended periods of time;
- Ability to understand customer needs and appropriately influence decision making;
- Excellent customer service skills and demonstrated ability to understand customer needs and appropriately influence decision making;
- Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof;
- Knowledge of Project management practices and terminology;
- Strong software and computer skills, including MS Office applications;
- Home-based;
- Occasional travel may be required.