Contracts Associate - Clinical Trials

We are looking for an experienced homebased Contracts Associate in Sweden. The Contracts Associate is responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials. Provide support to the clinical team in the pricing, planning, execution, issue resolution and management related to site/investigator budgets and contracts.
Responsibilities
· Responsibilities include but are not limited to:
· Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.
· Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
· Analyze investigator grants for fair market value aligned with regional knowledge and the sponsor grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
· Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
· Determine potential needs for contract amendments and manage amendment lifecycle.
· Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
· Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
· Assume responsibility for all aspects of legal document and metrics tracking.
· Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
· Adhere to SOPs, ethics and departmental compliance as determined by CDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with C&G, CDO and operating companies
· Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
· Comply with requests from QA and auditors.
Qualifications
You are:
Experienced of contract negotiation in the pharmaceutical clinical trials. You will be able to demonstrate solid communication and independent working styles and problem solving abilities. You should demonstrate innovative spirit and strong interpersonal skills.

Requirements:
· Bachelor’s degree in appropriate scientific or business disciplines
· Must have a working knowledge of the clinical development
· Experience negotiating budgets and contracts in the clinical trial development
· Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
· Fluency in English and Swedish is required
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.