Clinical Contracts Manager

Recruiter
United BioSource Corporation.
Location
All Cannings
Posted
18 Oct 2018
Closes
31 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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.

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, scanning, filing and archiving original agreements.
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 and financial guidelines.
Attend study team meetings, teleconferences, kick-off meetings, and investigator meetings, as necessary.
Appropriately escalate UBC risks associated with clinical study agreements, investigator payments and other operational vendor contracts if needed.
Maintain repository of operational contract templates as well as country specific budgets, requirements and timelines, and make available to project teams as needed. Monitor changes for potential template impact.
Maintain repository of approved fallback language and apply as appropriate in negotiation process to accelerate closure.
Contribute to and/or lead improvements to contract tracking tools, metrics reporting, operational effectiveness and investigator payment administration.
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 and budgets 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
Mentor junior members of the team
Please note this is not an in-house legal role!


Requirements:


Bachelor’s Degree, Graduate Degree (law education) is essential
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


About UBC

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.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

Keywords

Clinical / Clinical Research / Clinical Operations / Late Stage Research / CRA / Clinical Research Associate / CPM / Clinical Trials / Clinical Project Manager / UK / Europe / London / Geneva / Switzerland / Germany / France / Spain / Italy / Sweden / Belgium / Netherlands / Portugal / Oncology

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