Clinical Operations Manager (Contract)

Clinical Operations Manager

​17/Sep/2021

​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

• Accountable for overall Clinical Operations activities
• Accountable for Unblinded COM responsibilities
• Facilitate study budget and site contract approval and negotiations and ensure timely finalisation of the required clinical trial agreements for sites in designated regions
• Conduct risk assessment categorization activities with cross-functional study teams, including protocol and site-level risk assessments and identification of deviations
• Provide input to areas including strategy development, clinical program and regulatory strategies
• Manage collaboration between project managers and other functional groups to ensure effective and efficient project progress
• In conjunction with the Quality Team, create and maintain study level clinical monitoring plans, study start up plan, SOPs/WIs and feasibility form; eCRF creation and adaptation to specific protocol requirements
• Review, support and contribute to appropriate metrics related to clinical trial conduct
• Review, adapt and approve clinical study documents, including ICFs, study protocols Ethics/Regulatory packages and provide feedback as pertinent to clinical operations
• Oversee feasibility and site identification activities in designated regions for new clinical studies

Key things we are looking for

• Onboard, train, coach, mentor, manage and oversee activities of CRAs and CTAs to ensure the successful start-up, monitoring and execution of Phase I-IV trials in respective region, in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines.
• Generate resource allocation plans including CRAs and Site Managers personnel requirements for designated regions
• Develop performance measures and evaluate CRAs and Site Managers performance and quality of work via periodic co-monitoring visits and evaluation of performance measures.
• ​Review and approval of visit reports for sites in designated regions in accordance with monitoring plan and relevant SOPs
• Ensure sites within assigned region are inspection ready; leading task forces for Site Inspection Readiness
• Develop and oversee the implementation of CAPAs in audited study sites
• Contribute to overall clinical operations team knowledge by sharing best practices and leading improvement initiatives
• In conjunction with Site Directors and Site Managers, develop and cultivate strong site relationships with Investigators and site staff
• Clinical Management at international clinical study sites, in Europe and North America; also doing site visits to assess the Vendor and CRO’s work

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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