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About the role
Key responsibilities & impact- Accurately interpret and translate sponsor protocol requirements into the protocol specific database to generate a Statement of Work for the CLS project.
- Leverage technical, therapeutic area, client, and company specific process knowledge to provide a comprehensive and complete database design.
- Interact with external clients regularly through all duties and responsibilities.
- Liaise with internal departments to understand full company capabilities and assess feasibility of requests to meet client needs related to study design.
- Act as a consultant to advise on study design choices and work with the Global Study Manager (GSM) to highlight risks and budget impacts associated with study design.
- Expand consultancy capability at study program levels.
- Display strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design.
- Coordinate internal processes and communications related to study design and ensure the eventual follow up is integrated into the database and global monitoring plan.
- Perform quality self-review.
- Ensure that all customer requirements with relation to study design are documented and acted upon.
- Act efficiently in an environment with dynamic timelines and priorities.
- Display appropriate self-organization and ability to manage conflicting priorities.
- Participate in functional meetings and provide input, keeping processes up to date.
- Comply with our internal Central Lab Global Project Management strategy.
- Manage a portfolio of global and local studies with varying complexities.
- Support a culture of continuous improvement, quality, and productivity.
Requirements
What you’ll need- Bachelor’s degree in a life science
- 6 or more years of experience working in the clinical research industry or within a lab environment
- Experience working directly with internal or external customers
- Strong relationship building and management skills
- Familiarity with clinical or preclinical research protocols
- Strong planning, organizational, and problem-solving skills
- Excellent verbal and written communication skills
- Excellent skills using computer applications (e.g. Windows, Excel, Word)
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Database DesignClinical Research ProtocolsQuality Self-ReviewProject ManagementData Documentation
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsRelationship BuildingSelf-Organization
