Lead, Clinical Data Management

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause.

Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). At Amylyx, we're bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable. Our mission would not be possible without each individual perspective within our team. It's a culture that uses unconventional thinking for unsolved problems.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.

THE OPPORTUNITY

The Lead, Clinical Data Management provides project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. The Lead, Clinical Data Management is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team. The successful candidate partners with key study team members to facilitate implementation of a robust and clear data strategy plan for the studies assigned; works with DM leads at CROs and other vendors to ensure timely execution. This position reports to the Head, Clinical Data Management.

THE RESPONSIBILITIES

• Provide project-level oversight of clinical data management activities, monitors and reports on overall study progress
• Develops project timeline and monitors data deliverables for all assigned studies in collaboration with cross functional team members and vendors
• Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans - identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).
• Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
• Develops risk mitigation or action plans and oversees execution when appropriate
• Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.
• Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) and external customers (CROs, external data vendors, etc.).
• Oversee the performance and quality issues with vendors and escalates to management and develops appropriate risk mitigation as needed
• Support study-level audit and inspection readiness activities as needed

REQUIRED QUALIFICATIONS

• Bachelor's degree in Life Science or related discipline required.
• 8-10 years of clinical data management experience, previous work with CROs and Data Management vendors is required, working in a global/cross cultural setting is preferred
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices
• Excellent interpersonal, communication, and organizational skills with the ability to manage multiple programs and processes simultaneously in a fast paced, team-based environment
• Proven ability to build relationships and manage expectations with CROs/external vendors
• Experience with eTMFs pertaining to CDM documentation

PREFERRED REQUIREMENTS

• Experience in managing data management tasks for Phase III clinical trials
• Experience in supporting study-level audits and regulatory inspections
• Expertise with Medidata Rave EDC system

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx's Remote Work Policy which includes:
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.