Project Manager - Clinical SME

Project Manager - Clinical SME

Posted 3 days ago by 1752302344

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Negotiable
Outside
Remote
USA
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Summary: The Project Manager - Clinical SME role involves leading clinical research projects within a remote setting, requiring a strong background in Clinical R&D. The position emphasizes project leadership, management, and collaboration with cross-functional teams, while also identifying opportunities for process automation and AI integration. Candidates must possess experience in clinical trials and related processes, with a focus on effective communication and stakeholder engagement.

Key Responsibilities:

  • Lead the planning and execution of clinical research projects.
  • Define project scope, goals, schedules, and resource allocation.
  • Manage project budgets, timelines, risks, and ensure deliverables meet quality standards.
  • Oversee cross-functional teams, including data scientists, engineers, clinicians, and regulatory specialists.
  • Support implementation of systems used in pharmaceutical R&D, such as regulatory information management or quality management systems.
  • Demonstrate knowledge of clinical data flow, data architecture, and data mapping.
  • Identify opportunities for process automation and AI adoption within clinical R&D workflows.
  • Act as a liaison between technical teams and business stakeholders, ensuring clear communication and alignment.
  • Communicate effectively with internal teams, external vendors, and clinical sites.
  • Present project updates and strategic recommendations to senior management and clients.

Key Skills:

  • Experience in Clinical R&D or a division of a large pharma company.
  • Knowledge of clinical trials, patient recruitment, trial design, data management, monitoring, R&D pipeline management, and regulatory submission.
  • Project leadership and management skills.
  • Strong communication and collaboration abilities.
  • Experience with regulatory information management or quality management systems.
  • Understanding of clinical data flow, data architecture, and data mapping.
  • Ability to identify opportunities for process automation and AI integration.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Title: Project Manager - Clinical SME

Location: 100% Remote

Duration: 6+ months contract

IV: Phone and Video

Visa: No H1b/CPT

Need LinkedIn

** CLINICAL R&D Experience is a MUST ..

AI experience is a plus !

Clinical R&D Background:

  1. Experience of working in a Clinical R&D organization or a division of a large pharma company.

clinical trials, including patient recruitment, trial design, data management, monitoring, R&D Pipeline management, regulatory submission etc (at least a few of them)

  1. Support implementation of systems used in pharmaceutical R&D, such as regulatory information management or quality management systems.
  2. Demonstrate knowledge of clinical data flow, data architecture, and data mapping.
  3. Identify opportunities for process automation and AI adoption within clinical R&D workflows.
  4. Work in a matric environment with clinical, regulatory, and tech teams

  1. Project Leadership and Management:
    1. Lead the planning, execution of clinical research projects.
    2. Define project scope, goals, schedules, and resource allocation.
    3. Manage project budgets, timelines, risks, and ensure deliverables meet quality standards.
    4. Oversee cross-functional teams, potentially including data scientists, engineers, clinicians, and regulatory specialists.

  1. Communication and Collaboration:
    1. Act as a liaison between technical teams and business stakeholders, ensuring clear communication and alignment.
    2. Communicate effectively with internal teams, external vendors, and clinical sites.
    3. Present project updates and strategic recommendations to senior management and clients.

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