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, Massachusetts, with some flexibility to be partly home-based.
The ideal candidate will have proficient experience within oncology clinical trials, 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:
Requirements and skills:
- 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.
What CROMSOURCE can offer you?
- 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;
- 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.
A full benefits package including:
Who will you be working for? About CROMSOURCE:
- Medical, Dental, and Vision insurance
- Flexible Spending Account
- 401k Retirement Plan with company match
- Disability and Life insurance
- Summer Fridays
- Vacation and Sick leave
- 11 Paid Holidays
- Education Reimbursement Plan
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
: If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002114 If you would like to discuss the role before applying, contact Alessandra.Bolognani@cromsource.com
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.
Keywords: Project management, project manager, oncology, clinical trials, CRO, Waltham, Massachusetts
Skills: Clinical Project Manager, Clinical Trial Manager, Senior Clinical Trial Manager, Project Leadership Location: United States, Waltham Share:
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