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Job Description
Salary: $150-165K
Location: Raleigh, NC (new office opening in Q1 2025, fully remote until then). Hybrid schedule: 3 days in the office, 2 days remote. They are still searching for office space but are looking within a few miles of the 540/40 intersection in RTP, which is central to most of the Triangle.
Travel: 20%, international and Domestic. International travel will be to the UK for phase 3 studies.
Interview Process: Three rounds with 1-2 interviewers in each round.
Top Requirements:
- Must be able to work onsite three days a week (nonnegotiable).
- Must have experience in one of the following: complex inpatient studies (ideally in ICU or NICU), critical care, or respiratory.
- RN, respiratory therapist, or coordinators are strongly preferred (half of the team consists of RNs or individuals with hospital experience).
- Open to candidates from either a CRO or Sponsor background.
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A small biopharma company is looking to add two Clinical Trial Managers to their team. In this role you will help to the Head of Clinical Operations (HCC) and will be responsible for supporting recruitment, initiation, conduct (day to day operations) and close-out of clinical trials and assist in the management and day to day operations of the CRA field staff.
Qualifications:
- RN, RT or bachelor’s degree in a science-related field or equivalent job experience.
- >5 years’ experience in the clinical trials field or a related field, 8+ years of industry experience.
- Would love to see those coming from a clinical background (RN, PA, etc.) with CRA experience, advantageous for field understanding and medical terminology familiarity.
- Prior experience supporting P2B & Ph3 studies - must have launch experience
- Prior experience working for both sponsor and CRO (3/2 split)
- Prior experience supporting blinded and unblinded Phase 2 & 3 studies. Main focus will be on blinded study.
- Therapeutics area: neonatal care, respiratory, intensive care, and oncology experience, ideally with intensive study involvement (not from asthma or allergy backgrounds). Focus on drug over device for this drug/device combination.
- Understanding and use of multiple EDC platforms
- Available to travel up to 25% - international & domestic (must have a valid driver’s license and passport)
- Able to work onsite 3 days/week in Raleigh, NC (new office opening in Q1 2025, fully remote until then).
- Clinical supply chain management experience, given the complexities of drug and device product logistics.
- Prior experience working in a startup environment
• Coordinating & tracking monitoring visits for the field clinical monitoring team
• Tracking and coordinating team project-specific and SOP training for the field CRA staff.
• Reviewing, tracking, and finalizing monitoring visit trip reports and follow-up letters
• Coordinating the trial start-up efforts and management of the regulatory documents to ensure sitAssoe readiness for SIVs
• Managing the eTMF
• Managing clinical supplies in conjunction with the unblinded CRA.
• Creating and implementing study-specific plans (clinical monitoring plan), clinical monitoring tools and documents.
• Assuring compliance with SOPs, local regulations, and CFR, ICH/GCP guidelines.
• Participation in initial creation of screening, data collection forms, and database/data entry screens.
• Support site specific development of IRB submission packages or Pharma central IRB submissions.
• Field/Remote Monitoring/Co-monitoring as needed.
• Participation in site qualification, site initiation visits, interim monitoring visits an close-out visits as necessary.
• Perform field evaluation of monitors at pre-determined intervals or as needed.
• Oversight of study progress and day to day operations with sites (PIs, Coordinators, & other research staff).
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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