Senior Manager, Clinical Data Management
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What you'll do
- 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
What they're looking for
- Bachelor’s degree or higher in Life Science or related discipline
- Minimum 6 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
Nice to have
- 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
- Certified Clinical Data Manager
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.
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 or higher in Life Science or related discipline
- Minimum 6 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 Qualifications
- 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
- Certified Clinical Data Manager
Work Location and Conditions
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
- You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote locatio
Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Company
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