Clinical SME - Project Manager

Clinical SME - Project Manager

Posted 2 days ago by 1752302394

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Negotiable
Outside
Remote
USA
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Summary: The role of Project Manager - Clinical SME involves leading clinical research projects within a remote setting, focusing on the life sciences domain. Candidates must possess a strong background in Clinical R&D, including experience with clinical trials and regulatory submissions. The position emphasizes project leadership, communication, and collaboration across various teams, with an additional advantage for those with AI experience. The role is expected to start in July and has a duration of over six months.

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.
  • Act as a liaison between technical teams and business stakeholders.
  • Communicate effectively with internal teams, external vendors, and clinical sites.
  • Present project updates and strategic recommendations to senior management and clients.
  • Support implementation of systems used in pharmaceutical R&D.
  • Identify opportunities for process automation and AI adoption within clinical R&D workflows.
  • Demonstrate knowledge of clinical data flow, data architecture, and data mapping.

Key Skills:

  • Experience in a Clinical R&D organization or a division of a large pharma company.
  • Knowledge of clinical trials, patient recruitment, trial design, data management, and regulatory submission.
  • Experience with regulatory information management and quality management systems.
  • Strong project leadership and management skills.
  • Ability to create and drive roadmaps for strategic goals.
  • Knowledge of clinical data flow, data architecture, and data mapping.
  • Experience in process automation and AI adoption within clinical R&D workflows.
  • Excellent communication and collaboration skills.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:
  1. ROLE: Project Manager - Clinical SME
  2. DURATION: 6+ mo / REMOTE Starts July
  3. VISA: h1b ok
  4. Domain: Life Science
  5. Rate: Your best rate

** 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.

SKILLS MATRIX

YES / NO

Years

SKILLS REQUIRED

Clinical R&D Background:

Working in a Clinical R&D organization or a div. of a pharma co.

clinical trials,

R&D Pipeline management,

regulatory submission etc (at least a few of them)

Create and drive roadmaps for strategic goals

Support implementation of systems used in pharmaceutical R&D

Regulatory information management

Knowlege of clinical data flow

data architecture

data mapping.

process automation clinical R&D workflows.

AI adoption within clinical R&D workflows.

Create and adjust project plans when needed for dynamic clinical needs

Project Leadership and Management:

Lead the planning, execution of clinical research projects.

Define project scope, goals, schedules, resource allocation.

Manage budgets, timelines, risks, ensure deliverables meet quality standards.

Oversee cross-functional teams, data scientists, engineers, clinicians, regulatory specialists.

Domain: Pharmaceuticals

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