Clinical Project Manager I

Hybrid - Waltham, MA

Job Description:

Responsible for providing successful project management and support for all assigned clinical trials, from start-up through study closeout. Ensures all members of cross-functional team are operating in line with the protocol requirements and following all industry regulations and standards.

Responsibilities & Accountabilities:

· Responsible for the development, management, and maintenance of study deliverables [i.e., timelines, study plans, etc.] through collaboration with internal and external stakeholders.

· Provides leadership and oversight of assigned cross-functional team, ensuring proper training, development, and insuring successful and timely completion of project timelines and deliverables.

· Develops and oversees performance plans, tracks progress and provides feedback.

· Provides proactive identification of potential risks and development/implementation of actions to avoid or mitigate and communicates these findings to internal and external stakeholders.

· Guides customers and leads internal teams on customer-specific paradigms, document templates, data management standards, project plan, status reporting, and any area where operational efficiencies are required.

· Assists with operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. Will also assist with development and/or review of departmental SOPs/WIs.

· Maintains thorough knowledge and understanding of client contracts, deliverables, business practices, and key performance indicators. This includes maintaining thorough knowledge of all key client agreements (e.g., Service Level Agreement, Governance Agreements, Rate Cards).

· Consistently performs duties within established Policies, Standard Operating Procedures, Work Instructions, and Study-Specific Procedures in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPAA).

· Participates in performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and reader billing as needed.

· Participates in internal and external project-related audits and audit-related activities as needed and upon request.

· Assists with all other departmental requests as needed and upon request.

Education & Experience:

· A Minimum of 3 years of Clinical Trial Experience

· Extensive knowledge of Voiant Clinical workflows and systems

· An undergraduate degree, or certificate, in science, business or related field, preferred.

· Working knowledge of GCP

· Medical Imaging knowledge or experience a plus

· Proficient in Microsoft Word, Excel, PowerPoint, and experience using database software

· Excellent organizational skills and attention to detail

· Strong written and verbal communication skills

· Proactive and ability to work independently.

· Flexible and able to manage multiple priorities and deadlines.

· Positive attitude, ability to work within a team environment.

Job Type: Full-time

Benefits:

  • Competitive Salaries
  • 401(k) matching
  • Generous paid time off and holiday
  • Internet allowance for remote workers
  • Employee assistance program
  • Employee discount
  • Flexible spending account
  • Health savings account
  • Life insurance
  • Professional development assistance
  • Tuition reimbursement

Schedule:

  • 8 Hour Shift
  • Monday to Friday
  • No Weekends

Work Location: Hybrid – 135 Beaver St., Waltham, MA 02452

Candidates can send their CV to hr@voiantclinical.com. Please feel free to reach out to HR Talent & Culture with any questions.