Company: Premier Research
Location: Madrid, Spain
Closing Date: 02 Jan 17
Salary (£): Competitive
Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic Contracts Specialist to join our team!
The Contract Specialist is responsible for all aspects of preparation, negotiation and execution of required contractual agreements associated with an investigative site participating in a clinical study. The Contract Specialist assumes responsibility on quality deliverables throughout the conduct of the study with and concentration on Site Start Up and up to site initiation.
Key duties will include:
Preparing, negotiating, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed.
Negotiating final CDA and CTA templates with clients, sites, and the internal project team.
Managing all required contractual agreements with investigator sites. This includes distribution, negotiation of budget and language, tracking and finalization.
Independently communicates with client designee on all contract-related items.
Escalating issues appropriately to the Project Manager.
Proactively identifies site contract related risks and potential roadblocks.
Preparing contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.
Participating in project-related meetings.
Maintaining communication with sponsor, project team and sites regarding status of all contractual requirements.
Assisting in development and implementation of ne
To qualify you will be:
An Undergraduate degree holder or its international equivalent in business administration, legal studies or life sciences from an accredited institution.
In terms of experience you will meet the following requirements:
Previous demonstrated legal experience with contract language, budget development and negotiations
Proven related industry experience (CRO preferred)
Ability to work with internal and external customers/vendors to meet project- specific goals
Interacts with site, clients and other functional areas as secondary project contact for contracting issues and questions
Assist with mentoring and training staff
Manages time and project requirements base on study deliverables
Provides input in local SOPs and WI
Support for the creation of internal training materials
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