Senior Clinical Data Manager

Responsibilities

The Senior Clinical Data Manager will be responsible for leading and coordinating Data Management

(DM) deliverables from database design & set-up, through cleaning and reporting to database

locking, ensuring that the completeness, accuracy, and consistency of clinical data meets the quality

standards and regulatory requirements for analysis and reporting.

This includes:

• The EDC build (set-up, eCRF design, database validation, etc) and user acceptance

testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks.

• Ensure optimized data collection, flow and access across EDC and non-EDC data sources
• Responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases.
• Develop and implement data structure standards based on CDASH/SDTM
• The role will operate as a key member of the Clinical Operations team working closely with other

departments

• Serve as primary contact for DM with all relevant parties both internally (e.g., Project Management,

Clinical Monitoring, Biostatistics, and other functional groups) and externally (e.g., external vendors,

investigational sites)

• This position also provides leadership and expertise in relevant data management areas and cross-
• functional initiatives, including the development of departmental processes, tools, and training of staff
• Provide strategic input into the design of data flow across EDC and non-EDC data sources
• Creatively define, develop, implement, and enforce use of systems that simplify and improve clinicaldata capture and quality e.g., continuously test clinical data systems to identify functional issues, define and execute mitigation strategies to identify functional issues and anomalous data, etc.,
• Plan and project the resources required including management of tasks, timelines, risk, and quality
• Keep track of the DM budget, forecasts and manage changes of scope requests
• Participate in the review of study documents (e.g., protocol, electronic case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
• Develop, review, and maintain project-specific DM documents including data management plans(DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
• Provide project metric reports, status updates, study progress, feedback, and advice to project team on site performance issues, data trends and protocol non-compliance etc.
• Perform and/or coordinate various data reconciliation activities; examples include (but not limited to) UADEs, medical conditions, and (other) external laboratory data, etc.
• Contribute as Subject Matter Expert (SME) in the field of CDM activities to the evaluation/improvement and standardization of processes and procedures within the Quality Management Syst

Requirements

What You'll Bring to the Team

• Qualifications:
• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience

• Minimum of 8 years of data management experience preferably in the diagnostic industry and/or

pharmaceutical/biotechnology industries

• Experience with web-based EDC software systems (Castor, Rave, ClinCapture, Medidata, etc.) and

other tools for managing clinical studies (medical coding dictionaries such as MedDRA and WHO Drug

• Experience in CDISC conventions, i.e., CDASH, TAUGs, SDTM terminology and hands on

experience implementing these models

• In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
• Experience in development and implementation of Clinical data management standards and

procedures and preemptively identify data and system issues, and mitigate risks to data quality

• Knowledgeable, thorough experience with relational database components with development,

validation, execution, maintenance, documentation, testing, and archival of clinical data.

• Highly detail oriented with special attention to quality and quality control
• Ability multitask and handle multiple responsibilities simultaneously; able to prioritize
• Well organized and able to work under tight deadlines
• Excellent interpersonal skills, including verbal and written communication
• Ability to work in a fast-paced and informal startup environment
• Strong problem-solving skills with desire to improve upon established processes
• Ability to simplify complex issues into understandable concepts
• Ability to translate guidelines, rules, and regulations in clear and usable recommendations

Benefits

What You'll Get as Part of Our Team

• An inspiring working culture where our core values are more than just words on a page. We walk the talk!
• Base Salary Range: $133,000 to $199,000 for Senior Manager, $112,000 to $168,000 for Manager, takes into account factors including experience, skills, location, education and other compensation and benefits being offered. These may include: competitive equity, bonus, 401k matching, paid time off, and other benefits (medical/dental/vision, STD/LTD, Life/AD&D, HSA, FSA).

• Comprehensive Benefits: medical/dental/vision, STD/LTD, Life/AD&D, HSA with employer contribution, FSA, employee assistance program, paid time off, generous holiday schedule, equity and 401k matching.
• Additional Benefits: hybrid and remote work options, commuter benefits, home office subsidy and learning & development opportunities.

Who We Are

Exai Bio (exai.bio) is an early-stage diagnostic company with a powerful oncRNA and AI-based liquid biopsy platform. Our proprietary technology delivers unprecedented insight into cancer and disease biology from standard, non-invasive blood samples. We are the next generation of liquid biopsy!

Our mission is to deliver the earliest and most accurate diagnosis of cancer. Why? Because we aspire to enable a world where cancer can be detected early, diagnosed accurately, treated in a personalized and targeted way, and ultimately cured.

We know that people are our greatest asset and we are rapidly building a rock-star team of talent. Our people are driven by the mission, inspired by the vision of the future, and are committed to living our core values (integrity, openness, teamwork, exploration, and kindness) that connect us to our work and to one another.

What We Value

Our core values represent what we stand for as a team. This is what we believe in. Everyday, we strive to align our behaviors to these core values in everything we do.

Integrity – Our thoughts and actions are true to science and to people. We do the right thing.

Openness – We recognize and respect our differences – and embrace learning from them.

Teamwork – We are team players who trust and respect each other.

Exploration – We are explorers, putting curiosity into action.

Kindness – We are kind whenever possible – and we believe it’s always possible.

More About Us

Exai Bio was founded with technology from the UCSF laboratory of Dr. Hani Goodarzi, and consists of veteran leaders in the RNA biology, liquid biopsy, and artificial intelligence/machine learning fields from both academia and industry.

We value a diverse, inclusive workforce and we provide equal employment opportunities for all applicants and employees. All qualified applicants will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.

We do not accept unsolicited resumes from agencies or other third parties and will not pay fees associated with such resumes. Agencies, please do not send resumes to any of our locations, employees or email addresses.