Description
Senior Endpoint Adjudication Specialist Hybrid in BA/Argentina
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
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We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
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We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Working under the limited guidance and mentorship of a Manager, MCAM or above (Line Manager) or designee:
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Serve as a functional lead as a representative for the MCAM team on small to large-sized projects or programs with clinical trial committees.
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May serve as a Project Lead in MCAM stand-alone projects.
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Interact and collaborate with other functional groups, service providers, investigative sites, and customers.
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Attend Trusted Process or customer meetings to discuss strategy for trial committee requirements.
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Attend internal and customer meetings as an MCAM representative, to address MCAM-related agenda topics, and provide status reports.
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Manage MCAM scoped services ensuring objectives are met, in good quality, on time and within budget including the following activities:
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Develop and maintain the project-specific Committee Charter and Event/Endpoint Adjudication Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
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Develop specifications required for setup of the committee’s collaborative workspace and/or electronic adjudication platform and outcome forms.
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Manage and attend meetings with service providers. Setup purchase orders for service providers supporting MCAM services.
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Manage requests for additional data from adjudicators.
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Liaise with Clinical Data Sciences, Medical and Safety teams to identify any potential unreported clinical endpoints or events requiring adjudication.
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Write event/endpoint narratives for inclusion in adjudication package or distribution to other committee members.
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Develop timelines for committee meetings and liaise across functional areas to ensure deliverables are met.
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Provide regular and timely status updates to internal and customer project teams regarding MCAM scoped services, including risks to delivery such as timeline delays and serve as a central point of contact for MCAM-related project issues and solicit support from Line Manager or MCAM Subject Matter Expert(s), as needed.
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Contribute to relevant functional project plans to ensure alignment with the Committee Charter and Event/Endpoint Adjudication Plan.
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Ensure MCAM project documentation is maintained on an ongoing basis and ensure required documentation is filed completely and accurately in the Trial Master File (TMF).
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Responsible for management of MCAM scope, including identification of MCAM out of scope activities and overburn, revenue recognition (if delegated this task by project lead)
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Participate in customer, internal or agency audits and inspections, as required.
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Oversee the work performed by MCAM members assigned to the same project.
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Train and mentor Committee Specialists.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Independently provides customer-focused management of Medical Committee & Adjudication Management (MCAM) scoped services to set up and manage clinical trial committees. This role is responsible for coordinating with the Project Lead and functional leads, customers, service providers, investigative sites, and committee members to ensure that MCAM contracted services are delivered in line with project scope. Key duties include the implementation and oversight of processes to align with a clinical trial protocol and contracted services. Is responsible for managing trial committees from project initiation through to completion by communicating effectively with all stakeholders.
