Senior Contract Specialist

Jan 13, 2022
Required Education
Masters Degree/MBA
Position Type
Full time

11 January 2022

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

  • To administer all contract management processes

  • To assist the Project team with the collection and tracking of CDAs

  • To produce site-specific contracts and to ensure harmonisation to reflect Sponsor’s master service agreement terms.

  • To coordinate drafting and review of site-specific contracts, budgets and associated documents with Legal and Clinical Operations Manager and to ensure resolution of all queries and appropriate sign off according to Bionical Emas SOPs

  • Prior to sign off, to perform quality control and review of contracts for completeness and accuracy and to ensure that corrections are appropriately made and documented

  • To serve as the point of contact between site contract staff, if appropriate, and internal and external customers regarding initiation, amendment and finalisation of clinical site contracts.

  • To provide timely tracking of contracts and status and filing within Bionical-Emas electronic trial master file (eTMF) system

  • To Identify gaps and/or areas for improvement in systems and processes

  • To identify possible contract or process operational risk and to proactively work within the team to provide solutions. To escalate deviations to department leadership, Project Management and/or Legal

  • To maintain and actively support the review and development of contract templates, budget templates and site-specific files and databases

Key things we are looking for

  • University Graduate or appropriate level of experience. A degree in Business Administration and/or paralegal training or an advanced degree is an advantage

  • Experience in the Pharmaceutical, Research or CRO industry

  • Significant prior experience in working with site or vendor contracts, that includes experience gained within Clinical Research Organisation and/or Biopharmaceutical companies

  • General understanding of business and financial principals that relate to service agreements

  • Ability to organise competing priorities logically and review contractual risks and issues

  • Understanding of the principals of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws

  • Experience of building and negotiating budgets

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.