Clinical Data Manager Details

Clinical Data Manager

Alector - South San Francisco, CA

Employment Type : Full-Time

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 own 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 ensuring compliance with the corporate timelines and scope of work. This position will report to the Head of Clinical Data Management. The CDM is also responsible for leading or supporting company process improvement initiatives.
During the first year, your goals will include:

• Support the clinical study team by helping to implement 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
• Provide expertise to the standardization of Clinical Data Management processes and process improvement and efficiency
• Oversee 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)
• Coordinate the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy
• Provide input to vendor and technology (e.g., EDC) evaluation, qualification and selection
• Work with the pharmacovigilance group to establish processes for reconciliation between the safety and clinical database on an ongoing basis
• Able to use clear judgment to tackle problems and to call out issues with proposed solutions, as necessary
• Must ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical CDM Practices internally and with CDM vendors via regular process auditing. Ensures CDM project documentation is in an inspection-ready state
• May need to provide input to RFP development and contract negotiation, as needed.

We'd love to hear from you if you have:

• Bachelor's Degree in a scientific subject area
• 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 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 deliverables, 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, disability status, or any other characteristics protected under applicable federal, state, or local laws.
Alector is a great 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.
BenefitsWhile 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 take on these challenges with us. Come join us.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.