Contract & Proposal Manager- Regulatory Affairs

England  ‐ Onsite
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Description

New opportunity has been created due to work load for an expert with background in contract and proposal management.

This role requires maintenance of Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines, services in the development of training related to Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines as required.

Tasks required:

* Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies.
* Support creation and maintenance of fallback language and negotiation guidelines related to contract templates.
* Support training on contract templates and fallback language and provide training to first line negotiators and others as required.
* Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiators.
* Work with the legal department to create risk assessments to support the decision-making process.
* Assess risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide guidance to 1st line negotiators, stakeholders and others as required.
* Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business.
* Lead contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies.
* Coordinate with cross-functional departments to ensure consistency and compliance with process, external communications and policies.
* Assist in coaching/mentoring staff members.
* Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed.
* Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as
determined by GCDO management as well as R&D companies, corporate, HCC and QA guidelines.
* Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge.
* Monitor departmental processes to ensure compliance with corporate policies.
The role is home based and can be based in any EU country

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start date
04/2021
Duration
10 months
From
Michael Bailey Associates
Published at
16.03.2021
Project ID:
2070092
Contract type
Freelance
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