Job description

Senior Clinical Trial Manager

Overview:
We are seeking a highly skilled Clinical Trial Manager to lead and manage clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements. The successful candidate will be responsible for ensuring that clinical trials are conducted efficiently, within budget, and in a timely manner, while maintaining high-quality data.

Key Responsibilities:
Develop and implement clinical trial plans, including timelines, budget, and resource allocation

Manage study start-up activities, including protocol development, site selection, and feasibility assessments

Manage the conduct of clinical trials, including site initiation, monitoring, and close-out activities

Ensure the safety of study participants and compliance with regulatory requirements

Ensure the quality of clinical trial data through data review and query resolution

Manage study budgets and timelines to ensure that trials are completed on time and within budget

Oversee study team members, including study coordinators, data managers, and monitors

Collaborate with cross-functional teams, including clinical operations, medical affairs, biostatistics, regulatory affairs, and safety, to ensure successful trial execution

Prepare and review study-related documents, including protocols, informed consent forms, study reports, and regulatory submissions

Participate in study-related meetings, including investigator meetings, site initiation visits, and study team meetings

Ensure compliance with GCP and other relevant regulatory guidelines

Qualifications:
Bachelor's degree in life sciences or a related field; advanced degree preferred

5+ years of experience managing clinical trials in the pharmaceutical or biotech industry

Knowledge of GCP and other relevant regulatory guidelines

Excellent organizational and project management skills

Strong leadership skills and ability to manage a team

Excellent communication and interpersonal skills

Ability to work effectively in a cross-functional team environment

Ability to manage multiple priorities and adapt to changing timelines and priorities

Strong attention to detail and analytical skills

Proficient in Microsoft Office and other relevant software applications

We offer a competitive salary and benefits package, including health insurance, 401(k) retirement plan, and paid time off. If you are a highly motivated, organized, and detail-oriented individual with a passion for clinical research, we encourage you to apply.

PRECISION LIFE SCIENCES

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