United BioSource Corporation.
*This position is available office based in London, or home based in UK, Spain, France, Germany, Italy, Netherlands and Norway.*
*Brief Description: *
Manage clinical study contracts and /or any other ancillary agreement required to conduct allocated projects as well as confidentiality disclosure agreements and letters of delegation.
Liaise with relevant project management team, clinical, legal and other internal departments and sponsors to ensure contract management support throughout the life of the project. Plan, initiate, and negotiate contracts directly with study sites.
* Bachelor’s Degree, Graduate Degree (in Law) preferred
* Legal background required
* Approximately 4 years’ experience in directly initiating, negotiating and executing contractual language/agreements.
* Three to five years’ experience in a clinical trials environment, biotech or pharmaceutical industry preferred
* Excellent English verbal and written communication skills
* A high degree of competence in Word, Excel and other MS Office programs
* Ability to manage effectively in a multi-cultural matrix environment
* Must be able to work independently and possess excellent organizational skills and flexibility to manage multiple priorities and take on new initiatives to support rapid growth
*Line Management and Supervisory Responsibilities*: No
*Specific Job Duties:*
* Serve as the primary operational contracts point person for assigned studies.
* Manage the preparation and contract negotiation process, including template development, documentation of contract template and revision, approvals, signature process, status tracking and reporting.
* Directly interface with sponsor project management and legal to develop clinical study agreements (templates up to final draft), letters of delegations and confidentiality disclosure agreements within UBC and sponsor legal.
* Attend study team meetings, teleconferences, kick-off meetings, and investigator meetings, as necessary.
* Appropriately escalate UBC risks associated with clinical study agreements if needed.
* Maintain repository of operational contract templates (if and as available) and make available to project teams as needed. Monitor changes for potential template impact.
* Maintain repository of approved fallback language (if and as applicable) and apply as appropriate in negotiation process
* Contribute to and/or lead improvements to contract tracking tools, metrics reporting and operational effectiveness.
* Provide leadership and direction, including training, to project staff (internal and third-party vendor staff) in their communications with investigative site personnel regarding investigator agreements to ensure cooperative and effective communications between sites and UBC.
* Contract negotiations of other types of study-related agreements, including laboratory, radiology and consulting service agreements related scopes of work.
* Facilitate requests for pricing and narratives related to operational contract management and investigator payments for RFI/RFPs, client presentations or other UBC business needs.
* About 10% travel required
* Other duties as assigned by management
* Mentor junior members of the team
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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