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Senior Clinical Project Manager, United States, MA - L

Employer
ClinChoice
Location
United States
Salary
Competitive
Start date
28 May 2021
Closing date
26 Jun 2021

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Job Details

Description:

Are you an experienced Clinical Project Manager looking to join a great company with a reputation for looking after their employees and having a great work-life-balance. This is a permanent, full-time position within our internal CRO. Initially office based in Waltham, MA, or home based within easy-reach of the office for in-person meetings.

The ideal candidate will have proficient experience within oncology clinical trials or other complex therapeutic areas, 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 budget, while being fully GCP, ICH and SOP compliant.

Major Accountabilities:
  • 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 safety of patients and completeness/integrity of data;
  • Ensures set-up and maintenance of all systems in order 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 in order to meet study timelines;
  • Ensures global feasibility of site and has oversight of the contractual agreements;
  • Organizes and participates in Monitor's and Investigator's Meetings.


Requirements and skills:
  • Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical/nursing field;
  • At least 3 years of experience as a Clinical Project Manager;
  • Preferably experience in Oncology or other complex therapeutic areas;
  • Experience of monitoring clinical trials to ICH/GCP
  • Excellent interpersonal, verbal and written communication skills (in English);
  • Ability to motivate both individually and collectively;
  • Excellent problem solving capability through early identification;
  • Excellent computer literacy;
  • Travel may be required.


  • The Benefits of Working for Cromsource in the US


    • 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, sick leave and holidays
    • Dedicated Line Manager
    • Monthly meetings with line manager
    • Full performance and development process with
    • Team events and end of year party
    • 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


    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.

    The Application Process:

    Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002538

    or please contact Laura.Guascone@cromsource.com for more information.

    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, oncology, clinical trials, CRO, Cary, North Carolina
    Skills: Clinical Project Manager 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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