Associate Clinical Project Manager – Sponsor Dedicated
IQVIA
Google Cloud Platform
Senior Director, Clinical Operations
Immunovant
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $275,000 - $285,000 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformPMP
About the role
- Contributes to program strategy, resourcing, budgeting, project plans, and oversight for clinical studies to achieve clinical program goals
- Guides and supports trial management activities including budget management, study management, CRO/Service Provider oversight, risk mitigation and Good Clinical Practices
- Leads the CRO/vendor selection strategy to support assigned studies, oversee the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies
- Supervise and direct clinical trial activities to ensure adherence to internal SOPs, as well as adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes
- Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational/regulatory documents.
- Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines through establishment and reporting of clinical performance indicators KPIs/KQIs, and through innovative and agile methodology to improve processes
- Provide input to the drafting of governance documents, SOPs, work instructions, and other resources
- Leads and/or participates in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality or other business objectives
- Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation and oversees appropriate progress and timely completion of trials and deliverables according to established milestones and goals
- Collaborate cross-functionally to oversee the clinical operations aspects of work processes involving site management, medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
- Provide input to the drafting of governance documents, SOPs, work instructions, and other
- Manage clinical operations manager/assistants, including effective performance reviews, feedback, mentoring, coaching and development of staff
Requirements
- Bachelors in Life Sciences with an advanced degree preferred
- At least 15 years of experience in the pharmaceutical industry, with at least 10 years in a clinical leadership role on a cross-functional drug development project team. Experience working at a CRO, small pharma or biotech company is a plus.
- PMP is a strong plus.
- Experience executing complex global development programs across all phases of clinical research (Phases 1-4)
- Experience leading a cross functional team is a strong plus
- Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations is required
- Experience selecting and oversight of CROs/vendors required
- Experience in rare disease therapeutic areas and patient engagement strategies preferred
- Ability to function in a fast pace, dynamic environment
- Ability to deal with ambiguity
- Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
- Strong interpersonal and negotiation skills
- Proven complex problem solving and decision-making skills
- Must be a demonstrated self-starter and team player with strong interpersonal and communication skills
- Excellent written and verbal skills
- Must display strong analytical and problem-solving skills
- Direct supervisory experience
- Unrelenting dedication to delivering quality results
- Integrity, in word and action
- Willingness to roll up your sleeves to get the job done
Benefits
- Equity and other forms of compensation may be provided as part of a total compensation package
- Full range of medical, dental, vision, 401k
- Unlimited paid time off
- Parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementbudget managementrisk mitigationGood Clinical Practices (GCP)clinical protocolsclinical performance indicators (KPIs/KQIs)cross-functional team leadershipglobal development programsclinical research phases (1-4)CRO/vendor selection
Soft skills
interpersonal skillsnegotiation skillsproblem solvingdecision-makingcommunication skillsanalytical skillsself-starterteam playeradaptabilityintegrity
Certifications
PMPadvanced degree in Life Sciences
