Senior Clinical Lead

propharmagroup; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

ProPharma in Raleigh, NC seeks an experienced clinical operations lead to oversee investigator site management and monitoring across studies from startup through closeout. You will lead the site management resource for clients and internal teams while ensuring activities meet plans, SOPs, and GCP/ICH guidelines.

You will develop training materials, review monitoring deliverables, and collaborate with cross-functional teams to ensure timely site initiations and issue resolution.

Qualifications

• 5+ years of experience in clinical research is preferred, including CRA experience.
• Experience mentoring and developing junior staff.

Responsibilities

• Oversee investigator site management and monitoring activities for assigned studies.
• Lead site management resource for client, site, and internal study teams.
• Ensure monitoring activities follow study plans, SOPs, GCP/ICH, and regulations.
• Develop and deliver study-specific training materials and trainings.

Skills

CRA activities

Team leadership

Regulatory knowledge

Communication skills

Education

Bachelor's degree

Tools

MS Office

eTMF

CTMS

EDC

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Essential Functions :

• Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study.
• Functions as the lead site management resource for the client, investigational site, and the internal study team.
• Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations.
• Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams.
• Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance.
• Responsible for the review and approval of study monitors' site visit reports for the investigational sites on assigned studies within appropriate process requirements.
• Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring .
• Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process.
• Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc.
• Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements.
• Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed.
• Maintains timely and effective communication among team members and site personnel as assigned.
• May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate .
• Other duties as assigned.

Necessary Skills and A bilities :

• Demonstrated ability to perform CRA activities at an advanced level .
• Demonstrated ability to lead a team of Clinical Operations . professionals in the successful execution of clinical trials .
• Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals .
• Experience managing/mentoring and developing junior staff.

Educational Requirements:

Bachelor's degree preferred. Candidates with equivalent combination of education, training, and experience will be considered.

Experience Requirements:

• 5 + years of experience working in clinical research is preferred, including clinical research associate experience. Prior LCRA and/or Clinical Lead experience is preferred. Excellent verbal and written communication skills; interpersonal and presentation skills are required .
• Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations.
• Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials.
• Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.