Data Manager

Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.

The Data Manager supports the Lumos Pharma Clinical Operations and Clinical Development Departments with data management for ongoing clinical research. Data Manager will be responsible for overseeing the collection, validation, integrity, and management of clinical trial data to support regulatory submissions and internal decision-making. The Data Manager will be responsible for providing support across all stages of clinical research from startup to closeout, as well as for process improvement activities.

This role will work with internal colleagues and external vendors to ensure delivery time, quality, and cost expectations, and will perform day-to-day data management activities in accordance with ICH guidelines, regulatory requirements, and the company's standard operating procedures.

The Clinical Data Manager is responsible for leading the clinical data management activities for assigned clinical trials including case report form design, electronic data capture (EDC) database development, processing external data, oversight of medical coding, data review, and database close/lock procedures in accordance with SOPs, Good Clinical Practice, and ICH Guidelines. The position is responsible for ensuring data management timelines and quality for their projects within the data management/clinical operations team.

• Protocol review
• Develop or review the database definition file to oversee the creation of CRFs/eCRFs. Data Validation Plans, and Edit Check Specifications
• Perform or oversee User Acceptance Testing (UAT) of the eCRFs and Edit Checks for the database in development
• Manage change requests during the course of the trial after the database is Live

• Write CRF/eCRF Completion Instructions for in-house managed trials; review for outsourced trials
• Create the Data Management Plan (DMP) (hard copy and electronic) and update throughout the study for in-house managed studies; review/create for outsourced trials
• Write study-specific Manual Review Guidelines for in-house managed studies; review for outsourced trials
• Oversee Data Transfer Agreements with ancillary vendors
• Develop and implement critical variables quality management plans to maintain audit and inspection readiness

• Perform or oversee manual review of all CRFs/eCRFs generating queries as needed for in-house managed studies
• Ensure review and upload of all external data (e.g., labs and PK data)
• Medical coding for in-house trials; review for outsourced trials
• Track and resolve all queries for in-house trials; review for outsourced trials; SAE reconciliation
• Produce and/or review data listings
• Manage cross-functional reviews of clinical data to identify potential safety signals and support regulatory reporting (DSUR, SUSAR etc.)
• Provide Data Management summary reports to management and Clinical Operations; ad hoc reports from the database, as requested
• Ensure that the database is closed and locked at the end of the trial
• Resolve complex data issues to support timely decision-making for interim analyses

• Attend trial and project team meetings
• Manage Data Management timelines with outsourced vendors
• Author and implement DM and cross-functional SOPs
• Excellent oral and written communication skills, interpersonal relationship skills
• Knowledge of scientific methods, GCPs and regulations relating to clinical research
• Must have a working knowledge of computer technology and its application to the clinical environment
• Ability to read, analyze, and interpret information
• Must have the ability to analyze and interpret written and spoken English
• Must be able to work within time constraints and to think and respond quickly
• Must possess reasoning and problem-solving skills
• Must interact positively with co-workers and management
• The ability to work individually with minimal supervision, as well as part of a multidisciplinary team is needed

Education/Experience/

Skills:

• 2 years of experience in data management
• 2 years of experience in database development
• Basic knowledge of programming
• Knowledge of FDA and ICH, GCP regulations and guidance
• Excellent written and verbal communication skills
• Medidata Rave EDC System experience
• SAS experience
• Experience with CDISC standards (e.g. SDTM, ADaM, Define-XML)
• Rare disease trial experience

• BS degree in Computer Science, Statistics, or related field.
• 2 years of experience in clinical data management
• 2 years of experience building electronic data capture (EDC) databases…