At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration. Our team is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.
The Clinical Data Manager (CDM) will be responsible for providing quality management of clinical trial data in a rapidly-evolving environment, meeting industry standards. The CDM will lead the data management activities including Case Report Form (CRF) designing, database designing, oversight of CROs data managers and developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure. The CDM is responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in weekly and ad hoc meetings. The CDM is responsible for ensuring compliance with the corporate timelines and scope of work. This position will report to the Head of Clinical Operations. The CDM is also responsible for leading or contributing to company process improvement initiatives and vendor selection.
During your first year, your goals will include:
- Responsible for standardization of DM processes and process improvement and efficiency
- Accountable for complete project deliverables on schedule and according to quality standards and requirements from study start-up through archival
- Supports the clinical study team by providing standards for Data Capture and safety data, assessing the overall quality of data and identifying and advancing key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., frequency of queries and protocol deviations
- Responsible for vendor and technology (e.g., EDC) evaluation, qualification and selection
- Supports RFP development and contract negotiation, as needed. Identifies and implements solutions to global DM and EDC issues and concerns
- Work with the CRO pharmacovigilance and data management group to establish processes for reconciliation between the safety and clinical database on an ongoing basis
- Oversees related activities outsourced to DM service providers as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer/integration
- Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors, and management. Able to use clear judgment to solve problems and to call out issues with proposed solutions, as necessary
- Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices internally and with DM vendors via regular process auditing. Ensures DM project documentation is in an inspection-ready state
- Assists in preparation and support of clinical documentation for regulatory submissions
- Oversees the development of data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, Data Management Plans (DMP)
- Coordinates the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy.
- Provides input and participates in the development of clinical study documents including protocol and monitoring plans
- Participates in SOP development, training, process mapping, implementation of standardized work processes and other departmental activities
We'd love to hear from you if:
- Bachelor's Degree in a scientific discipline (Advanced degree preferred)
- Minimum of 6+ years in a pharmaceutical/biotech or CRO setting; global/international experience a plus.
- Experience supporting phase 1 to 3 clinical trials
- Knowledge and experience in EDC, key technologies (eg, IXRS) and industry standards including regulatory regulations, ICH-GCP guidelines, and CDASH/CDISC with understanding of Basic, SAS, SQL and/or other clinical programming applications.
- Strong understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
- Proficiency with MS Word, Outlook, and PowerPoint Experience in core DM activities (e.g., DM Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
- Strong interpersonal, organizational, and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
- Willing to travel if required
- Ability to prioritize workload and meet deadlines, demonstrate effective use of time and handle multiple assignments simultaneously
- Capable of actively identifying project challenges and risks, and proposing appropriate and strategic solutions to issues.
At Alector, we believe that high-performing teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a cure, where you’ll drive growth, this is the role for you. There is no limit to how far you can go with us.
While we’ve focused on what to look forward to during the first year and beyond, Day One is great, too: committed and driven colleagues, a bold and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these matter only if you’re excited to build and own something great, and tackle these challenges with us. Come join us.