Inflammatix is a host response-based diagnostics company, and we are seeking a Clinical Data Manager who will be a thought leader in directing data management strategies on one or more of our clinical trials. The ideal candidate is a highly organized individual who demonstrates excellent communication skills, individual initiative, and problem-solving capabilities. This person should be able to work independently and drive action items to completion with little oversight. You will have opportunities to orchestrate database builds, perform or delegate data cleaning and locking activities, while working cross-functionally with our Clinical Operations, Medical Monitors, Programming and Biostatistics departments and mentoring other team members. This is a study ownership role who will report to a Manager within the Data Management department.
- Manage end-to-end (start up to database lock) delivery of data management services while complying with Good Clinical Practices, applicable regulatory guidelines, company SOPs, Work Instructions and policies
- Strong leadership skills allowing you to offer guidance to the DM supporting study team, delegating activities where appropriate, while also participating as an active member of the study team and with other cross functional groups
- Mentor supporting staff by providing study training and onboarding and utilize experience to provide guidance to other team members
- Coordinate study activities with available resources to meet specified timelines. Escalate concerns for resourcing needs.
- Serve as the main point of contact and primary interface for data management vendors and labs and oversee external data transfers and deliverables in support of data review and reconciliation
- Works with other functions, liaising directly with internal customers (Biostats and Clinical Operations, etc) and contributes to the development of required documents and timelines as well as process improvement, risk mitigation and innovation as needed
- Ensures data management deliverables are met or exceeded within industry quality standards in a timely and cost-efficient manner
- Independently develop DM documents, including but not limited to eCRF design, developing data consistency/edit checks, eCRF Completion Guidelines (CCGs), performs data review, query management, data integration, medical coding and developing Data transfer Agreements with vendors for reconciliation activities
- Assist with troubleshooting and auditing of clinical data and databases in compliance with standard operating procedures, client and study specific guidelines and regulatory agency guidelines ensuring accuracy and integrity of data entered in EDC system
- Ensure that CDM documentation is filed in a timely manner in the Trial Master File (TMF) according to SOPs and study plans; periodically review CDM files for completeness and accuracy. Support study level audits and inspection readiness activities as needed
- Plans and actively participates in EDC development and testing of clinical data systems, as required both for studies and for standard library development
- Bachelors and/or combination of related experience in clinical, scientific, or healthcare discipline
- 3+ years’ experience, in a science related field preferred
- Proficiency in Microsoft Office: Word, Excel, Outlook and Powerpoint
- Excellent organization and communication skills
- Self-motivated to take on new challenges
- Track record of success in a deadline-driven and multi-task environment
KNOWLEDGE, SKILLS & ABILITIES
- Ability to wear many hats and adjust swiftly to changing priorities and completing deliverables
- Experience working with EDC platforms and data analytics
- Excellent attention to detail and orientation toward meticulous work
- Strong communication skills, both verbal and written
- Strong documentation and organizational skills while projecting a professional and positive attitude
- Strong interpersonal skills with demonstrated capability of working on multiple projects and programs simultaneously.
- Strong leadership skills, with the ability to motivate and drive assigned resources to successful completion
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time
- Compensation: Competitive and commensurate with experience; includes equity package
- Benefits: Medical, dental, and vision; 401(k), generous leave and more
- Location: Remote (Anywhere, US)
Inflammatix requires all employees to be vaccinated against COVID-19 (subject to any legally protected exemptions). For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.
Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.