Operations Lead, RS job in

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ICON is adding an Operations Lead, RS to our team in EMEA!

This is a full-time, home based position.

The Site Contract Specialist is responsible for the development, dissemination, negotiation and finalization of confidentiality and clinical trial agreements and related documents in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs.

Responsibilities:

Preparing, negotiating and monitoring compliance with, new and amended contracts for assigned sites/countries/projects.
Liaising with other departments on requirements for confidentiality and clinical trial agreements (and related documents) between customers and investigative sites necessary for the conduct of projects.
Providing advice regarding contractual expectations and requirements to investigative sites and internal and external customers.
Updating and maintaining contracts information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
Compiling, analyzing and summarizing legal and business positions of parties during the negotiation of contracts according to Sponsor/project specifications.
Examining contracts and related documents to ensure completeness and accuracy, as well as conformance to applicable laws, rules, precedents, company, customer and third party requirements in collaboration with internal and external experts.
Responsible for the development and review of contract templates, negotiation parameters and process documents.
Coordinating contract work across multiple Contracts Specialists.
May assist in training, mentoring and supporting new Contract Specialists.
May participate in the interview and selection process of candidates for Contracts Specialist positions.
Responsible for providing support to business development on contract aspects for proposals and budgets.
Participating in the improvement of the Quality Assurance System.
Completing other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs.

Qualifications:

Site Contract Specialist II

Experience:
- Minimum two (2) years relevant experience in Biotechnology, pharmaceutical, CRO or other health care setting
- Phase IV, Non-interventional Study experience preferred
- Supervisory/lead experience preferred

Knowledge/Skills/Attributes:

Thorough knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP...) and local requirements.
Strong written and verbal communication skills.
Proficiency with computer/software systems.
Strong organizational, time management, interpersonal, listening, conflict management and negotiation skills.
Ability to prioritize and coordinate multiple tasks and producing quality results in a timely manner with minimal supervision.
Ability to proactively identify issues and address/escalate as appropriate.
Ability to work both independently and in a team environment.
Ability to exert effective influence upon investigative sites and customers and advanced ability to effectively communicate business and legal rationale for contractual provisions and positions.
Entry-level ability to facilitate resolution of contentious contract provisions, as well as drive investigational sites and customers to contract resolution.
For non-native English speakers: possess excellent skills in written and spoken English (for international projects).

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Operations Lead, RS

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