Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Clinical Project Manager

  • Specialty:

    Engineering
    • City:

      Waltham
    • State:

      MA
    • 02452
  • Assignment Type:

    Direct Hire
  • Job Id:

    59022

Description

 
Are you an experienced and motivated Clinical Project Manager who takes pride in making an impact in the medical device field, driving project teams to deliver top-notice clinical research data? If so, apply today with your resume to this position with a cutting edge local medical device company impacting lives by the thousands!!

POSITION SUMMARY The Clinical Project Manager (CPM) is responsible for all Clinical Operations activities at the project level reporting directly to the Senior Director of Clinical Operations. The CPM directs, supervises and supports all clinical operations staff on the project team; liaises with study specific vendors and collaborates with project team members in other functional areas to ensure delivery of clinical research data. The CPM is accountable for the delivery of all clinical activities at the project level. The CPM will successfully meet internal and regulatory authority requirements in line with time, quality/scope and budget constraints. The CPM maintains a proactive, positive, results oriented work environment.

JOB FUNCTIONS/RESPONSIBILITIES:
The CPM:
• Ensures the effective selection, initiation and motivation of clinical studysites
• Plans and drives patient recruitment and retention
• Ensures that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by International Council for Harmonisation/Good Clinical Practice (ICH/GCP), protocol and other requirements.
• Takes the initiative to move the project/program forward and leads in country and global projects where applicable
• Leads and manages the clinical start-up and monitoring teams with focus on deliverables
• Supports in the development and review and writing of the protocol/study design, Case Report Forms, informed consent forms and other documents
• Plans and conducts initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable
• Assists the project team in the creation and maintenance of the Trial Master File according to internal SOPs.
• Develops clinical plans (e.g., Clinical Monitoring Plan, Communication Plan) as well as clinical tools, checklists and logs
 Prepares a risk management plan to mitigate unexpected events in the conduct of the trial
• Prepares and executes a site and patient recruitment and retention plan
• Drives the successful activation of trial sites according to time, quality/scope and budget parameterswww.pole3.com 2
• Serves as initial point of contact for all project team members, monitoring issues, vendors and other functional areas, escalating as required
• Ensures effective communication plans are in place for the project team and are actioned
• Monitors the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Works to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
• Works with the project team to ensure transparent and proactive communication regarding study progress and trial issues
• Escalates issues and provides escalation path for the team
• Attends project reviews and vendor meetings as required
• Supports study audits and responds to audit reports
• Assumes Site Monitoring responsibilities on specific projects or sites, as needed.
• Prepares forecasts for staff utilization over the life of the study
• Works to ensure team members are adequately assigned to the project and the project is appropriately resourced over project duration
• Assists in appropriate transition planning and stakeholder communication for any change in staff
• Identifies, recruits and manages central vendors as required per project scope
• Mentors and trains junior level staff
• Participates in corporate initiatives and actions that ensure the continued success of the company
• Manages site, vendor and study budgets and performs contract negotiations
• Manages site, vendor, and Monitor invoices/expense reports to be processed for payments
• Performs any other duties required to ensure the success of the trial and Third Pole
QUALIFICATIONS EDUCATION/EXPERIENCE:
• Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (e.g., registered nurse); or equivalent work experience required
• Minimum 5 years of clinical research required
• Working knowledge of ICH/GCP, ISO-14155, FDA, MDR, and EU Regulations, as applicable
• Experience working on cross-functional team
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
KNOWLEDGE, SKILLS AND ABILITIES:
• Knowledge of the principles of project management
• Demonstrated accountability for delivery on complex clinical trials
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• People management skills to motivate, enthuse and lead the team
• Excellent team player, collaborative and able to enable an effective team
• Ability to handle and prioritize multiple assignments in a fast-paced environment with changing priorities and meet deadlines and milestones
• Strong verbal and written communication skills
• Excellent organizational and time-management skills, able to meet deadlines
• Self-starter with lots of common sense and able to act on own initiative but also willing to be hands on
• Accountable, dependable and strong commitment to the projects
• Applies clear and consistent performance standards and handles problems decisively and objectively
• Maintains a positive, results orientated work environment
• Read, write and speak fluent English;
• Willing to travel as needed to fulfill the company’s objectives
• Knowledge of Microsoft Office Products (e.g., Word, Excel, PowerPoint, Visio)
 
 
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.  We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.  Apply today and experience “The DAVIS Difference”. 

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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