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Senior Clinical Project Manager, United States - P

Employer
ClinChoice
Location
United States
Salary
Competitive
Start date
24 Sep 2021
Closing date
7 Oct 2021

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Job Details

Description:
Location: United States - home based

Schedule: Full-time, Self employed; contractor-1099

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….

We have the rare opportunity available within CROMSOURCE for an experienced Senior Clinical Project Manager to join us in a sponsor-dedicated capacity with one of our partner pharmaceutical companies. You will be responsible for assuring the coordination of the operational aspects and proper conduct of clinical studies, including vendor management and compliance with ICH-GCP, Sponsor policies and SOPs.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:
  • Accountable for study execution, tracking and management of study delivery.
  • Oversee vendor and CRO activity.
  • May manage feasibility.
  • Tracks Regulatory and EC submissions, with medical team.
  • Maintains the global study budget, ensuring cost effectiveness and addressing and escalate issues as appropriate.
  • Ensures set up and maintenance of all systems in order to plan and implement the study and track progress.
  • Ensures appropriate clinical trial supply strategy is implemented and managed.
  • Develops recruitment plan, manages risk, monitors progress and implements contingencies as required.
  • Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
  • Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
  • Ensures for timely delivery of scientifically and operationally robust study documents.
  • Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
  • Ensures accurate maintenance and archiving of study records.
  • Ensures global feasibility of site contractual agreements.
  • Accountable for site and monitor training in operational aspects of the study.
  • Ensures monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented. Manages CRAs at the clinical level.
  • Ensures continuous direct contact with in-country personnel to provide ongoing operational support.
  • Accountable for study related communications and for resolution or escalation of operational issues.


Education and Experience:
  • University Degree in scientific, medical or paramedical disciplines
  • Significant clinical research experience in Project Management in the CRO/ Pharmaceutical industry
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Fluent in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel


The Application Process

Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for 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 who, 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 to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are 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.

Key words: Senior Clinical Project Manager, SCPM, SPM, Project Manager, CPM, PM, Study Manager, Clinical Study Manager, Clinical Trial Manager, CSM, CTM, SM, Submissions, Ethics, Contract Research Organisation, CRO, Outsourced, Sponsor dedicated, Pharmaceutical, Pharma, Pharmaco, Freelance, Contract, Temporary
Skills: Clinical Project Manager, Freelance Location: United States Share:

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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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