Senior Clinical Project Manager, United States - L

CROMSOURCE - USA - 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. Office based in Waltham, Massachusetts or Cary, North Carolina, or home-based anywhere in the United States, although applicants must be willing to attend meetings at our offices as needed.. 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 with 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 have the experience needed for this position, please apply directly to https://ift.tt/394IRQs If you would like to discuss the role before applying, contact Laura.Guascone@cromsource.com 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, Waltham, Massachusetts, United States, Home based, CPM, Study Manager Skills: Oncology, clinical trials, CRO, Project Management Location: United States Share: LinkedIn Facebook Twitter Email... - Permanent - Full-time

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