Medical Committee Manager (Endpoint Adjudication) at Syneos Health in Remote
Description Medical Committee Manager (Sr Endpoint Adjudication Specialist) Come discover what our 25,000
employees already know:
work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 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 SUMMARY Interacts with sponsors, project teams and consultants to ensure communication and evidence of adverse events reported by the investigational sites are presented to the Independent Adjudication Committee or Data Monitoring Committee(s) to assess subject safety within clinical trials. Oversees specific project teams defined by metric evaluation of study progress, quality control and fiscal reporting. JOB RESPONSIBILITIES Provides knowledge regarding international guidance / regulations related to committees to operational teams and/or sponsor. Primary interface with the sponsor, applicable teams, vendors or committee members assisting in selection and contracting of members, logistics and attendance of study meetings and maintenance of all committee-related documentation. Primary development of monthly financial reporting and approval of invoices ( department related services or vendors utilized) May serve as a supervisory contact (point of escalation) if the MCAM Specialist is considered the Primary Lead of the study. Responsible for development of study processes and documentation. This task may be delegated, however responsibility will remain with the Principal Specialist Evaluate, develop and implement action plans associated with study team metrics which require improved processing. Attend applicable meetings ( Trusted Process Meetings, team meetings, Scientific Committees Develop and/or review Patient Profiles / Event Summaries Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. Participate and direct activities related to department staff operations such as interviewing and selection. Mentor staff to increase education and proficiency. Assist team with work progression as needed. Qualifications QUALIFICATION REQUIREMENTS Bachelor's Degree in related Health Sciences - Registered Nursing Degree preferred. In lieu of a degree work related experience equivalent (6 years) in IAC / IDMC with demonstrated experience. A strong understanding of the use of medical terminology in multiple environments is expected. A strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outloook), voicemail and smartphone. The Manager will need effective organizational, interpersonal skills, communication skills, and group presentation skills; above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer-focused and have a disciplined approach to work is critical. Fluency in written and spoken English is essential. Requirements may include travel as required by the sponsor or study team (estimated at 25%)
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
employees already know:
work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 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 SUMMARY Interacts with sponsors, project teams and consultants to ensure communication and evidence of adverse events reported by the investigational sites are presented to the Independent Adjudication Committee or Data Monitoring Committee(s) to assess subject safety within clinical trials. Oversees specific project teams defined by metric evaluation of study progress, quality control and fiscal reporting. JOB RESPONSIBILITIES Provides knowledge regarding international guidance / regulations related to committees to operational teams and/or sponsor. Primary interface with the sponsor, applicable teams, vendors or committee members assisting in selection and contracting of members, logistics and attendance of study meetings and maintenance of all committee-related documentation. Primary development of monthly financial reporting and approval of invoices ( department related services or vendors utilized) May serve as a supervisory contact (point of escalation) if the MCAM Specialist is considered the Primary Lead of the study. Responsible for development of study processes and documentation. This task may be delegated, however responsibility will remain with the Principal Specialist Evaluate, develop and implement action plans associated with study team metrics which require improved processing. Attend applicable meetings ( Trusted Process Meetings, team meetings, Scientific Committees Develop and/or review Patient Profiles / Event Summaries Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. Participate and direct activities related to department staff operations such as interviewing and selection. Mentor staff to increase education and proficiency. Assist team with work progression as needed. Qualifications QUALIFICATION REQUIREMENTS Bachelor's Degree in related Health Sciences - Registered Nursing Degree preferred. In lieu of a degree work related experience equivalent (6 years) in IAC / IDMC with demonstrated experience. A strong understanding of the use of medical terminology in multiple environments is expected. A strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outloook), voicemail and smartphone. The Manager will need effective organizational, interpersonal skills, communication skills, and group presentation skills; above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer-focused and have a disciplined approach to work is critical. Fluency in written and spoken English is essential. Requirements may include travel as required by the sponsor or study team (estimated at 25%)
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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