Senior Clinical Contracts Manager - Home based in Europe
- Experience Level
- Experienced (non-manager)
Liaise with relevant project team, 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, physicians (as appropriate) and other ancillary agreements. Manage third-party vendors performing contract negotiations on behalf of UBC.
Support and lead initiatives and processes in respect to Clinical Contracts Management and support the review of requests for proposals related to Clinical Contracts Management tasks.
Identify legal risks in contracts and provide contractual language adaptations/revisions of contracts in line with UBC internal policies and as contractually agreed with Sponsors.
Support clinical contracts managers in contracts reviews, legal risk assessment, escalating and problem solving as required.
- Extensive experience (minimum of 5 years) in Contracts Management (at least 3 years in/at CRO, Biotech or Pharmaceutical required)
- Strong legal background: minimum 5 years experience in relevant legal reviews gained as a lawyer in law firms or as in-house lawyer in a legal department strongly preferred.
- Experience negotiating clinical contracts with hospital/facility, physician
- Working knowledge of GCP and functional components of clinical drug development
- Excellent interpersonal, relationship management and leadership skills
- Graduate Degree in Law (Master degree preferred)
- Excellent written and verbal English 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
- Ability to identify and manage legal risks in contracts
- Must possess excellent organizational skills with the flexibility to manage multiple priorities and take on new initiatives to support rapid growth
- Excellent leadership skills
- Commercial awareness and excellent understanding of industry standards
- Basic understanding of project management principles
- Pro-active, forward planning and strategic thinking
- Independent working
No Line Management. May be assigned with direct supervision of Clinical Contracts Managers, Senior Clinical Contracts Associates and Clinical Contracts Associates and indirect supervision of project and administrative staff in matters relating to the clinical contract negotiations process
Specific Job Duties:
- Serve as the primary operational contracts point person for assigned studies
- Manage the preparation and contract negation process, including template development and documentation of contract template and revision approvals, signature process, status tracking and reporting
- Directly interface with sponsor and legal to develop confidentiality and study agreement templates in line with UBC and as contractually agreed with sponsor
- Identify and manage legal risks in contracts
- Mitigate and avoid legal risks as required per UBC policies and as contractually agreed with Sponsor (i.e. through review resp. escalation if required)
- Adapt clinical contracts to different types as required for the study (as contractually agreed with the Sponsor and in line with UBC policies).
- Attend study team meetings, teleconferences, kick-off meetings, and investigator meetings, as necessary
- Provide support in cooperation with legal in respect to the creation of Clinical Study Contract Templates/contract language impacting UBC, and liaison with UBC senior management on risks associated with clinical study agreements in relation to ongoing projects handled by the clinical contracts management team
- Provide relevant input and lead the development of procedures (e.g. SOPs), policies, and standards for the development and negotiations of clinical study agreements
- Support the enhancement of the clinical contracts processes (clinical contracts negotiation and communication with UBC Project management team/ CRAs/Sponsors/internal or external Legal)
- Maintain repository of operational contract templates, as applicable and make available to project teams as needed and keep Clinical Contracts team updated. Monitor changes for potential template impact, as applicable
- Maintain repository of approved fallback language (if applicable) and apply as appropriate in negotiation process to accelerate and train CCMs to apply as appropriate in contract negotiations
- Contribute to and 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, UBC and Sponsor
- Provide the necessary support to ensure successful onboarding of new team members of Clinical Contracts Management
- Support and assist Project Management in preparing Requests for Information and Requests for Proposals in line with UBC policies
- Review (or support and assist PDs in reviewing) MSAs/SoWs in relation to newly assigned studies in line with UBC policies
- Support Bid Defense preparation and presentations and present (if appropriate)
- Liaise with site management in respect to the CRA performance of CRA related clinical contracts tasks
- Support and assist the review of Change Orders where requested by Project Directors
- Support and provide effective guidance and quality control to junior team members in understanding legal and contractual risks
- Approximately 10% travel required
- Other duties as assigned by management
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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