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Clinical Project Manager II, United States - P

Employer
ClinChoice
Location
United States
Salary
Competitive
Start date
24 May 2023
Closing date
22 Jun 2023

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Job Details

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 II to join our clinical team. Experience managing clinical trials with a CRO is preferred. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies. Candidates must live on the East Coast or Midwest.

As a Clinical Project Manager II, you will be responsible for managing the clinical projects ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.

Join our team and help us deliver clinical trials that will improve patients' lives.

Main Job Tasks and Responsibilities:
  • Manage and coordinate the assigned clinical projects
  • Manage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)
  • Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members
  • Submissions to the IRB; review monitoring visit report forms and customize ICFs
  • Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
  • Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
  • Assure the proper timelines of the assigned projects
  • Manage the budget for the project
  • Monitor the workload and the performance of the project team
  • Plan and monitor the tasks of the team in the specific areas
  • Coordinate the Clinical Research Associates and Clinical Monitors activity
  • Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activities
  • Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)
  • Collaborate with the CTAs in archiving activities
  • Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports
  • Deliver project-specific training
  • Organize and participate in Monitor and Investigator Meetings
  • Organize or take part in the periodic project update meetings
  • Provide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as required
  • Inform the Project Director/Leader about any issues
  • Perform co-monitoring visits for the assigned clinical projects as necessary
  • Act as a tutor for Project Coordinators and Project Managers I
  • Maintain relationships with the Sponsor, including providing project updates
  • Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit


Education and Experience:
  • University Degree in scientific, medical, or paramedical disciplines
  • Proven experience in clinical project management activities in the CRO/pharmaceutical industry including previous experience as a CRA or similar
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements


Specific Role Requirements and Skills:
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel


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, ½ day summer Fridays, sick leave, and holiday
  • Full performance and development process with end-of-year review
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


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: Clinical Project Manager, Clinical Study Manager, clinical trials, CRO, ICH-GCP, Project Management Location: United States

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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