Description
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.
Essential Functions
- 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.
Qualifications
- Bachelor's Degree
- Minimum 2 years of site contracting experience, including CTA (Clinical Trial Agreement) handling.
- Manage initial and amendment CTA drafting, review, negotiation, and execution.
- Lead site budget development and negotiations with investigational sites.
- Coordinate contract and budget negotiations to ensure timely execution.
- Coordinate investigator grants, proposal documentation, and contracting strategies for study start-up activities.
- Life sciences or medically related field including biopharmaceuticals clinical research experience.
- Strong communication and stakeholder management skills.