Premier Research is looking for a Clinical Lead II to join our Global Clinical Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you'll be doing:
Significantly contributes to the KOM meeting to ensure a strong and aligned SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer.
Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks.
Collaborates with PM and other support functions to ensure clinical systems are set up, UAT’d, maintained and supports project and reporting needs.
Collaborates with SSU team (eg Regulatory Submissions Leads, Site Start Up Associates, Contracts Leads/Specialists and/or Site Activation Leads) to ensure sites are identified, selected, approved by authorities/ethics committees and activated within the specified timeline/budget.
Plans/oversees patient recruitment and retention strategies. Partners with CRAs to drive individual site enrollment targets.
Reviews the study contract and budget to ensure clinical team members are trained on the contractual obligations, timelines and tasks. Provides detailed Time Entry Guidelines.
Collaborates with Project Manager and RSL to establish clinical and SSU project timelines and milestones throughout the study
Serves as an expert in the protocol, vendor manuals, informed consent forms and other clinical documents for CRAs and investigative sites
Serves as initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP).
Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables.
Leads the Protocol Deviation review meetings to ensure complete and accurate documentation of PDs for analysis and remediation of trends with Sites and CRAs.
Assists the project team in the creation and maintenance of the Trial Master File according to Premier Research and/or client SOPs. Ensures all visit report packages are filed according to SOPs
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Creates/maintains Clinical Monitoring Plan, MVR annotated reports, study-specific tools and training materials.
Delivers/coordinates training to the Premier clinical team and enlist therapeutic assistance where applicable.
Plans, schedules and leads clinical team meetings to ensure that clinical (CRA/CM) and SSU (SSUA, RSLs and contracts) are coordinating work and priorities to the timelines.
Ensures effective/efficient communication within team, PM, sponsor and sites on critical protocol clarifications or other instructions related to updates, requests or questions.
Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan.
Monitors start up metrics, activities and timelines on a regular basis. Tracks site id, selection and activation timelines, as well as timelines for CA/EC submissions and contract/budget execution.
Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines.
Works with the PM and Project Financial Analyst (PFA) to forecast clinical and SSU units to assesses any overburn. Adheres to the contractual and budgetary obligations of the study. Monitors burn rate for all clinical activities and escalate to Project Manager and CSD any potential OOS activities.
Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
Ensures timely patient data review (both central and onsite) by reviewing CRA/Central Monitoring workload backlog and their unit forecast and completion.
Proactively anticipates and remedies risk in the Risk Review meetings, by presenting clinical risks/issues with mitigations.
Ensures team members are adequately resourced to the project for the duration of the study.
Ensures protocol amendments, IB updates, SUSARs, ICF changes and site changes are distributed, reviewed, managed, documented and filed as necessary.
Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings.
Manages any clinical staff transitions, including hand-off documentation.
Ensures that site and study closure processes are followed including all data in clinical systems in a manner consistent with requirements
Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting.
Contributes to the creation, review and finalization of Root Cause Analysis and CAPA
May co-monitor or assess CRAs according to project and business needs.
May participate in Bid Defense activities
Supports junior CLs with coaching and mentoring as well as involvement in department specific initiatives.
Other activities as designated
What we are searching for:
Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
2 years of experience as a Clinical Lead. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred.
Epilepsy experience is preferred.
Broad experience across multiple therapeutic areas and indications is preferred.
Excellent communication, presentation and soft skills to manage teams and sites effectively.
Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets.
Advanced knowledge of ICH/GCP regulations
Advanced knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/ device development, and clinical monitoring and start up procedures
Strong MS Office computer skills
Working knowledge of clinical financials including understanding of budgets, pass- through and resource management
Fluent verbal and written English as well as the local language(s) required
Travel may be required for client meetings or co-monitoring visits up to 20%.