Totus Medicines, an innovative therapeutic drug discovery biotech, is just emerging from stealth. With a $40M Series A, Totus is poised to revolutionize drug discovery. For the first time, Totus is enabling genome-scale drug discovery to allow the identification of precision medicines for hard-to-drug targets. At its core, Totus is a chemical biology company. Totus’ novel proprietary platform allows screening at a rate more than 100,000 times faster than competitive technologies. Totus has pioneered the development of selective medicines for patients with genetically defined cancers and plans for its first program to enter Phase I by end of 2022. Totus also plans to expand their platform to create therapeutics targeted at neurodegeneration, infectious diseases, and others. We are searching for talented, passionate, high-energy candidates to join our growing team.
We are seeking a Senior Manager, Clinical Data Management to join our team! This role will report directly to the Vice President, Clinical Operations. This individual will be a member of the management team, working in close collaboration with our strategic partners and other vendors.
The Senior Manager, Clinical Data Management will be responsible for overseeing and managing the set-up, capture, quality, and analysis of data from multiple perspective, and retrospective clinical research programs. The Senior Manager, Clinical Data Management works collaboratively with internal and external colleagues and vendors to support clinical study objectives by ensuring the accurate and timely acquisition of clinical data via efficient Case Report Form (CRF) design, edit check design, and the query resolution process. The Senior Manager, Clinical Data Management will own data management activities including database vendor selection/oversight, CRF design, database design, development of Clinical Data Management Plans (CDMP), data entry and query resolution status tracking through database closure.
- Plan, manage, and coordinate data management activities and timelines for assigned clinical studies to ensure consistency of data across clinical programs and clinical program timelines
- Review clinical study protocols and research plans to ensure data collection and data management meet established standards
- Work closely with cross-functional clinical study team members to design clinical study databases, CRFs, edit checks specifications, and data standards across studies
- Lead User Acceptance Test (UAT) planning and execution for clinical study databases and associated CRFs and edit checks
- Lead in vendor selection and management of interactions with clinical database vendors
- Provide support to cross-functional study team members (Clinical Development, Clinical Operations, Medical Affairs) via the creation of clinical data reports and metrics (e.g., data listings, query listings, query resolutions, data completion)
- Oversight of vendors to ensure quality deliverables
- Lead frequent review of clinical data and associated metadata to ensure data integrity, completeness, accuracy, consistency, and compliance of clinical data
- Ensure study documentation is developed, maintained, and filed appropriately throughout the lifecycle of assigned clinical studies. This includes but is not limited to CDMP, CRFs, CRF Completion Guides (CCGs), edit check specifications
- Participate in the development, review and implementation of department and company standard operating procedures (SOPs), and other study related documents (e.g., Operations Manuals, Monitoring Plans, Budgets, Statistical Analysis Plan)
- Minimum of 5+ years of clinical data management experience in relevant field
- Bachelor's Degree, preferably in health sciences field
- Strong understanding of clinical trial and clinical data management principles from study planning through study closure
- Experience with web-based electronic data capture and clinical data management systems
- Experience with setting up clinical databases and experience working with clinical database vendors
- Working knowledge of medical terminology, industry standards (SDTM, CDASH), ICH/GCP guidelines, 21 CFR Part 11, and FDA guidelines
- Excellent interpersonal and written communication skills demonstrated by the ability to present to higher levels within the organization, including demonstrated presentation skills
- Demonstrated ability to handle multiple projects and prioritize effectively with proven ability to work independently and in a team setting.
- Ability to work on problems and comfortable with ambiguity
- Proven ability to lead in a manner that creates a motivated work environment
- Detail oriented and well organized
- Advanced working knowledge of spreadsheet software is a requirement. Additional experience with tools or software used for data visualization and reporting (Python, R, SAS) and Office 365 is a plus
- Some domestic travel may be required
What We Offer
A knowledgeable, high-achieving, experienced and fun team
A diverse work atmosphere
The chance to be part of a growing startup and the next success story
The opportunity to shape our company culture
Constant learning and dynamic challenges to help you grow and be the best version of yourself