Clinical Contracts Specialist

17 Sep 2021​

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Bionical Emas - the Company

​Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.

​With clients, staff and offices around the globe, we offer a varied and international experience.

Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations.  As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.

​Main Responsibilities

• Drafting and preparing site agreements and ancillary documents, for studies and EAP’s across the world
• Liaising with internal operational project teams, Bionical Emas’s central legal team, and clients to agree and approve appropriate template site contracts and ancillary documents
• Liaising with clients to agree letters of or powers of authority, where applicable, to permit negotiation by Bionical Emas of approved template site contract and ancillary document amendments (within set parameters), on behalf of clients
• Negotiating with sites (and where appropriate, project team and clients) to agree amendments to template site agreements and ancillary documents, including reviewing revisions to such documents proposed by sites and suggesting further appropriate revisions
• Escalating to line manager/Group Legal Director specific legal issues arising during such contract negotiation which fall outside the potholder's expertise/best practice/client permissions. Liaising with Legal Team members to resolve such issues
• Ensuring that all site agreements and ancillary agreements are negotiated in a timely manner, in line with client and project team requirements
• Ensuring that all agreed site agreements are signed in the approved manner and filed appropriately, in a timely fashion.
• Legal/regulatory research and presentation of findings appropriate to role
• Information gathering from colleagues at all levels and clear presentation of such information to applicable colleagues, clients and sites, as appropriate
• Develop and maintain strong knowledge of regulatory requirements and best practice/legal requirements and terminology relating to site agreements/relationships with clinical trial and EAP sites.
• Monitoring changes to government guidelines or regulations, as required, and submitting reports on pertinent changes, along with identifying and suggesting improvements to the Group’s systems/templates, in particular in relation to clinical contracting.
• Undertaking further tasks in conjunction with the Legal Department including, where required, monitoring legal inboxes, maintaining legal systems and databases, and extracting up-to-date, extracting applicable information from legal documents in order to create reminders, and monitoring and bringing forward date reminders.
• Completing internal and external training, as required by the business.
• Complying with all policies and procedures required by the Group.

​The above-listed tasks are not exhaustive. The list above provides a general indication of the tasks involved. ​However, the nature of the business is such that roles are likely to expand and develop over time.  All of the Group’s employees must be flexible in their work, in order to meet business needs.

Key Things we are looking for

• Previous experience of successfully drafting, negotiating and finalising appropriate clinical trial site contracts and EAP site contracts
• Strong understanding of contracts and legal terminology
• Strong existing knowledge of regulatory requirements and best practice relating to clinical trial site and EAP contractual relationships
• Strong written and oral communication and legal drafting skills
• Education to degree level
• Ability to and experience of working compliantly and successfully in a heavily regulated field
• Good commercial awareness
• Good interpersonal and teamwork skills
• Good planning, prioritisation and organisational skills
• Good problem-solving skills
• Ability to work flexibly and adaptably to shifting deadlines
• Good technology skills - ability to work with commonly used IT platforms and packages
• Ability to work under pressure and within time constraints
• Attention to detail/accuracy

​Make a difference

​At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference. 

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