Description:
Location: East Coast or Midwest, United States - home based
Schedule: Full-time, Permanent
CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Project Manager I. This is a permanent, full-time position within our internal CRO.
The ideal candidate will have proficient experience within complex clinical trials, such as Oncology, Respiratory, Ophthalmology, or Rare Diseases, as well as be able to work cross-functionally to ensure quality, budget, and timelines are met. You will be the central point of communication for all clinical trial-related activities to assure trials are conducted on time and within budget, while being fully GCP, ICH, and SOP compliant. Candidates must be based on the East Coast or Midwest.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities:
- Management of global, multi-center clinical projects: oncology rare disease, medical device, respiratory and ophthalmology
- Oversight of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.
- Ensures efficient streamlined processes are in place to deliver study to plan and ensure the safety of patients and completeness/integrity of data.
- Ensures set-up and maintenance of all systems to plan and implement the study and track progress.
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
- Tracks Regulatory and IRB submissions.
- Supports site feasibility efforts and study start-up activities including budget/contract negotiations.
- Accountable for study-related communications and for resolution or escalation of operational issues with all related project members and departments.
- Ensures development, review, finalization, and delivery of high-quality key clinical study documents to meet study timelines.
- Ensures global feasibility of the site and has oversight of the contractual agreements.
- Organizes and participates in Monitor's and Investigator's Meetings.
Education and Experience:
- Educated to degree level (biological sciences, pharmacy, or other health-related discipline preferred) or relevant experience in a medical/nursing field.
- At least 2 years of experience as a Clinical Project Manager.
- Preferably experience in Oncology or other complex therapeutic areas.
- Experience in monitoring clinical trials to ICH/GCP
Specific Role Requirements and Skills:
- Excellent interpersonal, verbal, and written communication skills (in English)
- Ability to motivate both individually and collectively, problem-solving solving capability through early identification
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)
- Travel may be required.
Our Benefits in the United States:
- Full health insurance benefits that include health, dental, and vision
- 401K Plan with 5% company match after satisfying 90 days of employment
- Short-term and long-term disability insurance
- Life insurance
- Paid vacation, summer ½ day Fridays, sick leave, and holidays
- Dedicated Line Manager
- Monthly meetings with the line manager
- Full performance and development process with
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
The Application Process
Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.
If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.
Who will you be working for?
About CROMSOURCE
CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Project management, Project Manager, Study Manager, Trial Manager, respiratory, rare diseases, oncology, medical devices, ophthalmology, clinical trials, CRO, Project Planning
Skills:
Oncology, Ophthalmology, Rare Disease, Respiratory, Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management
