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BD

Senior Clinical Project Manager

BD

. Prepare and/or review study-related and essential study start-up documents for assigned clinical trials .

Posted 9/15/2026full-timeRemote • New Jersey • United StatesSenior💰 $135,500 - $216,800 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in clinical project management, including leading cross-functional teams through complex clinical trials while ensuring compliance with regulatory standards. Proficient in financial forecasting, project budgeting, and managing relationships with stakeholders in a fast-paced environment.

Highest-signal resume keywords
Clinical Project ManagementCross-Functional Team LeadershipClinical Trial ConceptsPMP CertificationFinancial Acumen

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Clinical Study ExperienceProject ManagementTrial Master File ManagementMicrosoft Office SuiteTechnical Writing
Soft Skills
Exceptional CommunicationInterpersonal SkillsProblem-SolvingNegotiation SkillsOrganizational Skills
Tools & Technologies
MS ProjectExcel (Pivot Tables, VLOOKUP)
Certifications & Qualifications
PMP Certification
Industry Keywords
Clinical TrialsICH-GCPRegulatory RequirementsPharmaceuticalBiotechnology

Tech Stack

Tools & technologies
PMP

About the role

Key responsibilities & impact
  • Prepare and/or review study-related and essential study start-up documents for assigned clinical trials
  • Serve as Clinical Project Manager and ensure Study Management teams meet study timelines and deliverables
  • Oversee and lead study-specific study management resources
  • Develop and manage groups of studies for a business unit or large development program
  • Mentor other Clinical Project Managers
  • Provide critical thinking and leadership during clinical study execution issues
  • Write protocols, clinical study reports, and other clinical study deliverables
  • Lead or contribute to continuous improvement initiatives
  • Manage relationships with sites, principal investigators, CROs, and other study-related vendors
  • Develop and maintain integrated project plans and facilitate project meetings
  • Define, track, and report schedules, interdependencies, achievements, critical paths, and deliverables
  • Adapt work package deliverables based on study scale and complexity
  • Create resource and budget forecasts and timelines
  • Direct cross-functional team members and vendors on technical, protocol-specific, and operational study aspects
  • Identify and manage project risks and issues, including mitigations and contingencies
  • Maintain high-quality standards and compliance requirements
  • Perform other assigned duties

Requirements

What you’ll need
  • Bachelor's degree, preferably in the life sciences, clinical, or other relevant technical areas
  • Minimum of 5 years of clinical study experience in pharmaceutical, medical device, IVD, biotechnology, or CRO environments
  • Proven ability to lead cross-functional clinical teams through complex, global, multicenter studies from initiation through closeout
  • Minimum of 5 years of project management experience, preferably using MS Project
  • Strong knowledge of clinical trial concepts, international clinical research guidelines, and regulatory requirements
  • Hands-on experience managing Trial Master Files (TMF) in compliance with ICH-GCP and regulatory standards
  • Ability to influence cross-functional teams without formal authority
  • Financial acumen, including project budgeting, financial forecasting, and strategic recommendations
  • Strong project management, client relationship, and vendor relationship management skills
  • Ability to work independently with multi-level teams and manage multiple projects in a fast-paced, changing environment
  • Exceptional written and verbal communication, interpersonal, negotiation, and relationship-management abilities
  • Expert-level knowledge of clinical operations procedures
  • Exceptional problem-solving, organizational, analytical, and critical-thinking abilities
  • Strong leadership skills
  • Proficiency in Microsoft Office Suite, including expert-level Excel skills with Pivot Tables and VLOOKUP
  • Proven ability to work effectively in a remote environment
  • Ability to travel approximately 20% and reside near a major airport
  • Advanced degree desirable, including MS, MBA, PhD, MPH, PharmD, or MD
  • PMP certification highly desirable
  • Technical and/or medical writing experience desired

Benefits

Comp & perks
  • Comprehensive Total Rewards program
  • Reward and recognition opportunities
  • Competitive compensation and benefits programs
  • Flexible work-life balance considerations
  • Remote or field-based workplace arrangements as indicated
  • Learning, growth, and development opportunities
  • COVID-19 vaccination accommodation consideration pursuant to applicable law