Description
Job Location: Great Britain, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Company Overview:
For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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 start up, execution, and close out phase of the study.
- Functions as the lead site management resource for the client, investigational site, and internal study team.
- Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations.
- Provides input and supports development of study specific training material; provides study-specific training for assigned clinical monitoring teams as appropriate.
- Oversees quality of clinical monitoring deliverables to clients; may conduct Quality Co-monitoring visits to ensure data quality; develops solutions to optimize performance.
- Responsible for review/approval of study monitors’ site visit reports for investigational sites on assigned studies within appropriate process requirements.
- Works closely with clinical project manager; contributes to development of clinical study specific plans including but not limited to clinical monitoring plan; responsible for creating/updating study specific tools/templates related to clinical site management/monitoring.
- Assures compliance with study monitoring plan; collaborates with cross functional teams to ensure timely site initiation process.
- Leads/supports any study specific requirements related to site performance including patient recruitment/site payments/study material needs etc.
- Works closely with clinical project management team; provides status report on onsite initiations/enrolment/visit schedules/trip report completion etc. as per company/project requirements.
- Maintains timely/effective communication among team members/site personnel as assigned.
- May be responsible for supervision/admin oversight of direct reports within company expected framework (e.g., CRAs or other clinical team members).
- Other duties as assigned.
Necessary Skills And Abilities:
- Demonstrated ability to perform CRA activities at an advanced level.
- Demonstrated ability to lead a team in successful execution of clinical trials.
- Demonstrated ability to develop/maintain effective relationships with study site personnel; track record positively influencing them towards achieving goals.
- Experience managing/mentoring/developing junior staff.
Educational Requirements:
Bachelor’s degree preferred. Candidates with equivalent combination of education/training/experience will be considered.
Experience Requirements:
5+ years experience working in clinical research preferred including CRA experience. Prior LCRA or Clinical Lead experience preferred. Excellent verbal/written communication skills required along with interpersonal/presentation skills. Experience using Microsoft Office applications (Word/Excel/PPT) is necessary for preparing charts/tables/forms/reports/presentations. Familiarity working in eTMF/CTMS/EDC/DCT systems supporting conduct of trials is essential. Extensive understanding SOPs/work instructions/regional regulations/IHC guidelines/GCPs governing conduct is required.
Diversity Statement:
We celebrate our differences strive create a workplace where each person can be their authentic self We are committed diversity equity inclusion Employees encouraged unleash innovative collaborative entrepreneurial spirits With holistic approach Equal Opportunity Employer we provide safe space where all employees feel empowered succeed
Recruitment Notice:
ProPharma Group does not accept unsolicited resumes from recruiters or third parties Please no phone calls or emails regarding this posting
Lifelancer Information:
Lifelancer is a talent-hiring platform in Life Sciences Pharma IT connecting talent opportunities pharma biotech health sciences healthtech IT domains For more details find similar roles check out below Lifelancer link https://lifelancer.com/jobs/view/92b231708ea1f6b0714ccb0153ba659c Apply on Lifelancer Platform