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Senior Manager Clinical Operations
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
Über
Location: Boston, MA / Los Angeles, CA / New Jersey (Hybrid/Remote options available)
About DIP:
Deep Intelligent Pharma (DIP)
uses Generative AI to revolutionize clinical trials. Our platform enables pharma and biotech companies to digitally rehearse trials before they begin—making them faster, safer, and more cost-effective. From trial design and patient recruitment to analysis and regulatory reporting, DIP transforms the entire process into an AI-driven, proactive workflow
Position Overview:
We are seeking an experienced
Clinical Operations Manager
to lead clinical trial operations in the US market. This role is critical in building and managing our clinical research infrastructure, developing client relationships, and driving business growth. The ideal candidate will have a proven track record in CRO/pharmaceutical settings with expertise in both operational execution and business development.
Key Responsibilities:
- Client & Business Development
- Serve as primary point of contact for US-based clients and sponsors
- Lead bid defense presentations and proposal development
- Develop competitive budgets and draft clinical trial agreements
- Identify and pursue new business opportunities
- Team & Network Development
- Build and manage a network of Clinical Research Associates (CRAs) and freelance professionals
- Recruit, train, and mentor clinical operations staff
- Establish vendor partnerships and manage third-party relationships
- Site & Investigator Relations
- Identify, qualify, and activate clinical trial sites across the US
- Develop and maintain strong relationships with Principal Investigators and site staff
- Conduct feasibility assessments and site selection
- Project Execution & Oversight
- Oversee clinical trial execution from start-up through close-out
- Ensure compliance with FDA regulations, ICH-GCP guidelines, and SOPs
- Monitor project timelines, budgets, and deliverables
- Manage risk mitigation and quality assurance activities
Required Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
- Minimum 5-7 years of clinical operations experience in pharmaceutical or CRO setting
- At least 2 years of experience working in a Contract Research Organization (CRO)
- Proven track record of successfully managing multiple Phase I-IV clinical trials from start-up through close-out
- Direct experience in client-facing roles and sponsor relationship management
- Demonstrated experience in preparing clinical trial budgets and cost proposals
- Experience participating in bid defense meetings and RFP responses
- Proven ability to build, manage, and mentor clinical teams (CRAs, Project Coordinators, etc.)
- Experience establishing and managing relationships with clinical research sites and Principal Investigators
- Strong knowledge of
FDA regulations, ICH-GCP guidelines
, and 21 CFR Parts 11, 50, and 56 - Experience with clinical trial management systems (CTMS), EDC platforms, and other clinical technologies
- Excellent written and verbal communication skills with ability to interact at all organizational levels
- Strong negotiation and contract management capabilities
- Demonstrated project management skills including timeline and budget oversight
- Ability to travel up to 25-30% for client meetings and site visits
- Must be legally authorized to work in the United States without sponsorship
- Willingness to work from or relocate to
Boston, Los Angeles, or New Jersey area
Preferred Qualifications:
- Master's degree or MBA in related field
- 8+ years of clinical operations experience with at least 3 years in CRO environment
- Experience managing vendor networks and freelance CRA pools
- Active professional certification (CCRA, CCRP, PMP, or equivalent)
- Experience with global/multi-regional clinical trials
- Proven business development track record with measurable results
- Experience managing remote or geographically distributed teams
- Familiarity with EMA and other international regulatory requirements
- Prior experience in a start-up or rapidly growing organization
Please email your resume to -
Sprachkenntnisse
- English
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