Senior Clinical Lead
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 providesstudy-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 optimizeperformance.
Responsible for the review and approval of study monitors’ site visit reports for the investigational sites on assigned studies within appropriate processrequirements.
Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is notlimited to clinical monitoring plan.Also responsible for creating andupdating 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 timelysite 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 timelyand effective communication among team members and site personnel as assigned.
May be responsible forthe supervision and administrative oversight of the direct reports within the companyexpected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemedappropriate.
Other duties as assigned.
Necessary Skillsand Abilities:
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 maintaineffective relationships with study site personnel and a track recordof 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.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***