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Sr Clinical Trial Project ManagerKelly LifeScience & Clinical is currently seeking a Senior Clinical Trial Project Manager located in Raynham, MA or to work remote within the NE region. This role is a full-time, fully benefited position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time.The Project Manager will be responsible to plan, set-up, conduct and manage clinical trials to provide the safety and efficacy data required for regulatory approval of potential new drug. The Project Manager has direct clinical trial management experience with either a CRO or Sponsor and an overall responsibility to plan, manage, co-ordinate and lead clinical trial specific activities in accordance with Sponsor and CRO SOPs, ICH-GCP requirements, and FDA and local regulations.ESSENTIAL DUTIES/RESPONSIBILITIES:
Using strong knowledge of relevant regulations and guidelines represent the clinical research function to lead the development, writing and management of 2 protocols for a potential new drug therapy
Act as resource on clinical trial compliance on relevant drug therapy / drug-drive combination product questions to department and teams.
Provide operational support to efforts in the planning, execution and reporting of clinical trials
Maintain and negotiate vendor contracts
Assist with proposals and bid defenses as needed
Manage budgets and payments to investigator(s)/site(s)
Work with cross functional teams to conduct investigator identification, selection, training and routine monitoring
Lead the design and development of clinical study protocols and CRFs to ensure monitoring efforts fully complement the drug development process within established timelines
Responsible for setting up and managing product distribution
Conduct protocol investigator training sessions by telephone or at investigator meetings
Implement clinical trials (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), within a cross functional team.
Interface with the clinical operations, clinical quality assurance, data management, regulatory and NPD regarding day to day activities of clinical trials.
Contribute to the preparation and review of clinical program documents [clinical study protocol, clinical study reports (CSR) and submissions] and other study related documents assuring quality and consistency.
Develop, review and edit project plans (Clinical Monitoring Plan, Safety Management Plan and Communication Plan) to assure consistency with project goals
Working with cross functional partners, provides oversight and manages study conduct, ensuring client's goals and timelines are met and performs troubleshooting and problem-solving functions as the need arises.
Track and report project progress with regards of timelines, recruitment and financial status
Contribute to multidisciplinary task forces to support continuous improvement.
Liaise with site investigators and their staff.
Organize and facilitate project meetings related to study activities (study organization, initiation, execution and closure)
Apply GCP expertise in implementing clinical operations for clinical studies
Assumes responsibility for regulatory required study documentation and complies with standard procedures for collecting, maintaining and then archiving the materials in accordance with regulations, policies and client standard operating procedures
Present in written and oral format: group productivity, project status and key deliverables
This position does not require any direct site monitoring responsibilities but may perform co- monitoring as part of quality control program when specified in contract
Perform other duties as assigned or required
QUALIFICATIONS/EXPERIENCE/SKILLS:
Bachelor’s or Master’s degree in Biological Science or a related discipline
A minimum of 8 years of experience in a clinical development experience and clinical trial management experience with a pharmaceutical company, or CRO service provider of pharmaceutical clinical studies
2 years’ experience of project management in a team environment required .
Previous clinical project manager experience in conducting and managing Phase 1-3 clinical trials
Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
Requires strong background in understanding of relevant regulations and GCPs.
Strong scientific and clinical research knowledge is required
Ability to manage multiple projects
Critical thinking and analytical skills required.
Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions Excellent verbal and written communication, organizational and planning skills required.
Knowledge of financial management a plus.
Excellent problem solving/decision making skills.
Excellent organizational and planning skills with the ability to utilize technology and tools.
Excellent interpersonal skills. Ability to lead through influencing and negotiating.
Ability to function independently & effectively in a fast-paced environment.
Attention to detail skills required. Must take pride in work product results; strive towards 100% accuracy in work processes.
Proficient knowledge of MS Office, specifically Word, Excel, and PowerPoint, as well as, awareness of Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.
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