Sr Endpoint Adjudication Spec

Description

Senior Endpoint Adjudication Specialist (MCAM Manager)

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

• 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.
• 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.
• 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.
  
  

Position Summary

• The MCAM Manager provides customer-focused management of Medical Committee & Adjudication Management (MCAM) scoped services to support medical and safety oversight committees and their review of the safety of participants in clinical trials.
• Duties include liaising with committee members, customers, vendors and/or investigative sites to manage trial committees from start-up to final deliverables to the customer.
• Upon displaying proficiency, an MCAM Manager I may be awarded the opportunity to function at the Senior MCAM Manager level.
  
  

Responsibilities

Working under the guidance and mentorship of a Principal MCAM Manager, an Associate Director, MCAM, and/or a Line Manager:

• Act as a representative for the MCAM team on small to large-sized studies or programs with medical and safety oversight committees.
• Serve as a Functional Lead in full scope or multiple protocol projects. Interact and collaborate with other functional groups, vendors, investigative sites, and customers.
• Attend Trusted Process, internal and Sponsor meetings as a MCAM representative to discuss MCAM-related agenda topics and provide status reports.
• Manage MCAM scoped services ensuring objectives are met, in good quality, on time and within budget including the following activities: .
• Develop and maintain the study-specific Committee Charter and Event/Endpoint Management Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Develop specifications required for setup of the committee’s collaborative workspace and/or electronic adjudication platform under the guidance of a Senior MCAM Manager or delegate.
• Collaborate with customers, vendors, and committee members to develop electronic outcome forms and perform User Acceptance Testing (UAT) required for the execution of clinical endpoint or event reporting adjudication process.
• Perform secondary QC for clinical endpoint or event data and documentation to ensure completeness of adjudication package, redaction of Protected Health Information (PHI) and to identify any potential unreported clinical endpoints or events requiring adjudication.
• Develop timelines for committee meetings and liaise across functional areas to ensure deliverables are met.
• 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 required.
• Develop 3-way independent expert agreements and invoice management (tracking and confirmation of payment) for committee members as per contracted scope of work
• Contribute to relevant functional project plans to ensure alignment with the Committee Charter and Event/ Endpoint Management Plan.
• 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).
• Responsible for management of MCAM scope, including identification of MCAM out of scope activities and overburn, revenue recognition (if delegated this task by study lead)
• Participate in Sponsor, internal or agency audits and inspections, as required.
• Oversee the work performed by MCAM Specialist assigned to the same project.
• May mentor MCAM Specialists.
  

Qualifications

Qualifications Requirements:

• BS, MS or PhD in life sciences Medical, Pharmacy, or Nursing degree or equivalent combination of education and experience is required.
• Strong understanding of the use of medical and scientific terminology in multiple environments required.
• Prior experience in study coordination, a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
• Strong organizational and time management skills.
• Ability to work independently.
• Excellent communication and interpersonal skills, both written and spoken.
• Knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements.
• High proficiency with full MS Office Applications
• Ability to travel if necessary preferred (approximately 5%).
• High level of competence in English language.
  
  

Disclaimer

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 listed 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.

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.