Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.propharmagroup.com
https://www.propharmagroup.com
USD
160.00
HOUR
true
CTM
Posted: 12/04/2024
2024-12-04
2025-01-04
Employment Type:
Direct Hire/Perm
Job Category: Clinical Development and Operations
Job Number: 615551
Pay Rate: 160.00
Is job remote?: No
Country: United States
Job Description
START ASAP - TWO OPEN POSITIONS
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.
-------------------------------------------------------------------------------------
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:
• 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).
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.
-------------------------------------------------------------------------------------
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).
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Philadelphia, PA
Ready to embark on a new career adventure in the vibrant city of Philadelphia, Pennsylvania? Explore our job opportunities in the City of Brotherly Love and discover the countless growth possibilities this historic region offers aspiring professionals. From iconic landmarks like the Liberty Bell and Independence Hall to the mouthwatering Philly cheesesteaks and world-class art galleries such as The Barnes Foundation, Philadelphia is a treasure trove of culture and charm. With renowned theaters like the Walnut Street Theatre, professional sports teams like the Eagles and Phillies, and gorgeous outdoor spaces like Fairmount Park, Philadelphia has something for everyone. Don't miss out on the chance to make your mark in this dynamic city — browse our job listings now and take the first step towards your dream career!
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
