Clinical SME - Project Manager

Overview

Remote
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 6 Month(s)
No Travel Required

Skills

Clinical R&D
Project Manag
Pharma
Pharmaceutical
Life Science
Clinical SME
Clinical Subject Matter Expert
Subject Matter Expert
SME
Project Leadership
Project Management

Job Details

  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

Knowledge 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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