Clinical Research Project Manager

The Clinical Research Project Manager is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI and internal teams to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The Clinical Research Project Manager will coordinate all research-related activities, including the initial set-up of the study, study participant recruitment and retention, delivery of the intervention, data collection, entry, and quality control activities, protocol compliance and patient safety. He/She will also work on monitoring data quality assurance and quality control and study conduct. He/She will work independently in designing, coordinating, and implementing all assignments. The Clinical Research Project Manager is responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files. The Clinical Research Project Manager trains other staff in conducting study visits per the study protocol(s).

Requirements

• Schedule, screen and perform study visits
• Implement, and manage clinical trials from start to finish, including providing input to

protocol development, patient enrollment, and data analysis.

• Serve as the primary liaison between the company, clinical investigators, and regulatory

agencies to ensure compliance with all federal, state, and institutional regulations.

• Develop and maintain trial timelines, budgets, and resources, adjusting as necessary to

meet project milestones.

• Train and supervise junior clinical research staff, ensuring adherence to study protocols

and regulatory requirements.

• Prepare and submit regulatory documents, such as IRB applications, informed consents,

and progress reports, ensuring timely approval and compliance.

• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing,

to ensure seamless integration of clinical research findings into product development and

marketing strategies.

• Analyze and interpret clinical data, preparing detailed reports and presentations for internal

and external stakeholders.

• Stay abreast of industry trends, regulatory updates, and emerging technologies in software

as a medical device (SaMD) research, applying best practices to enhance trial efficiency

and effectiveness.

To succeed in this role, you should have the following skills and experience

• Bachelor's degree in a life sciences or related field

Minimum of 5 years of experience in clinical research coordination, preferably in the

medical device industry, with a proven track record of successful trial management.

• Comprehensive understanding of FDA regulations, ICH GCP guidelines, and other

applicable regulatory requirements.

• Exceptional organizational, leadership, and problem-solving skills.

• Strong communication and interpersonal skills, with the ability to work effectively in a team

environment and interact with all levels of management, clinical sites, and vendors.

• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC)

systems, and Microsoft Office Suite.

• Excellent verbal and written communications skills in English language

• Excellent interpersonal and organizational skills

• A pro-active, committed and motivated attitude

• Ability to work well in a team environment but also independently without significant

oversight

• Ability to efficiently organize and prioritize work within a multifaceted framework and set

deadlines

• Analytical skills sufficient to work and solve problems.

• Ability to work flexible hours to accommodate research deadlines.

• Ability to concentrate and focus in a work environment that contains distracting stimuli and

competing deadlines.

• Ability to be flexible in handling work delegated by more than one individual or in the course

of delegating work.

• Skill in managing diverse, complex tasks and information transfer among multiple

constituents.

• Sufficient math ability and knowledge of clinical trials budgeting processes to manage the

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