Kelly Services Sr Clinical Trial Project Manager in Raynham, Massachusetts
Sr Clinical Trial Project Manager
Kelly LifeScience & Clinical is currently seeking a Senior Clinical Trial Project Manager located in Raynham, MA , with partial remote working arrangements. 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.
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
Represents the company as the client's primary point of contact, at all times maintaining a high level of customer service and satisfaction, displaying precision in delivery and flexibility in approach.
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
Develops protocol specific procedures as needed.
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
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
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
2 years’ experience of project management in a team environment required.
Knowledge of project management software tools and management techniques
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.
Thoroughness and dealing with complexity
Ability and desire to work in a team-oriented environment
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.
Strong facilitation and coordination skills.
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.
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
About Kelly ®
At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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