Associate Clinical Data Management Director

Biometrics and Digital Science       ·       South San Francisco, CA       ·       Full time

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

The Associate Clinical Data Management Director (AD) will be responsible for providing quality management of clinical trial data in a rapidly-evolving environment, meeting industry standards. The AD will lead or support execution of data management activities to ensure all project data is consistent with the clinical development plan. The AD 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 AD is responsible for ensuring compliance with the corporate timelines and scope of work and will contribute to the development of best practices across CDM group. This position will report to the Director of Clinical Data Management. The AD 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 implementing 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 into 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
• 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 9+ 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 (e.g., 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.

#LI-BL1

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!

At Alector, we believe that hard-working 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.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

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.

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