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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities.
- Develop simple investigator grant estimates and proposal text to support the proposal development process.
- Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
- Ensure collaboration, including communication with sponsors, stakeholders, and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
- Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Assist in the creation and/or review of core scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Contribute to the collection, interpretation, analysis, and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
- Comply with contract management and quality standards.
- Provide administrative and operational support to investigator site contract analysts, managers, and directors as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
Requirements
What you’ll need- Bachelor's Degree in life sciences or health care
- 5-7 years relevant experience, including demonstrable experience acting as a contract negotiator
- Relevant sponsor or clinical research organization clinical site contracting experience
- Good negotiating and communication skills
- Good interpersonal skills and a strong team player
- Strong technical writing skills
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
- Good organizational and planning skills
- Strong knowledge of Microsoft Office and e-mail applications
- Ability to interpret pricing models and to prepare proposals, bid grids and budgets
- Good understanding of clinical trial contract management
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Benefits
Comp & perks- Health insurance
- Zero tolerance policy for candidate fraud
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
Contract ManagementBudgetingProposal DevelopmentGCP/ICH KnowledgeClinical Research ExperiencePricing Model InterpretationProject PlanningData AnalysisRegulatory Requirements KnowledgeSOP Application
Soft Skills
Negotiating SkillsCommunication SkillsInterpersonal SkillsOrganizational SkillsTeam Player