Senior Manager, Clinical Data Management (Remote Possible)
Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In initial clinical studies of FX-322, the company observed meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss which impacts more than 90 percent of all people with hearing loss. The company recently completed enrollment of a Phase 2a study, with results to be shared in Q2 2021. Frequency’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the Company is researching an array of additional degenerative diseases where PCA may be applied, including a pre-clinical program for remyelination in multiple sclerosis.
Reporting to the Director, Clinical Operations, the Senior Manager, Clinical Data Management, is responsible for leading all clinical data management activities for a project including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation and database close/lock procedures in accordance with ICH Guidelines and Frequency Therapeutics requirements. Additionally, this role is responsible for the Data Management timeline, budget, quality management, client relationship and the facilitation of all projects requiring the data management support.
A successful Senior Manager will contribute strong Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role is also the Frequency subject matter expert (SME) to DM process and technical/systems improvement initiatives.
Key Responsibilities Include
- Demonstrate subject matter expertise in all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager
- Advocate for the DM position within study team meetings and oversees vendor staff supporting DM work
- May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, data visualization, etc.
- May contribute subject matter expertise to support process improvement initiatives (e.g., data storage infrastructure, Master Control) and SOP authorship
- Oversee multiple DM vendors and provides training as necessary
- Participate in study and Data Sciences-level budget review activities for all DM tasks and line items
- Provide feedback and suggestions for improvement in DM vendor discussions
- Coordinate with the Vendor DM, Biostatistics, and Clinical on Database UAT, Edit checks, CRF completion guidelines, Data Management plan, Data Review Plan, change control processes and other study-specific plans as required
- Develop, generate and review project progress and/or metric reports, reporting summary of findings and data trends from vendor databases
- Perform vendor oversight activities across multiple studies. Proactively share and provide suggestions on how to improve vendor oversight with functional manager
- Document process related deviations and communicate these to manager
- May attend or participate in key industry conferences or related initiatives
- Develop a strong partnership with vendor Lead Data Managers to ensure program level deliverables are on track
- Lead the data review meetings with Medical, Clinical, Biostatistics and Programming in support of key reporting events or database lock plans
- BS/BA degree in a biological science, health-related or computer science field
- 8 plus years’ related experience in pharmaceutical or clinical research industries, with a minimum of 7 years experience as Data Manager, with progressive levels of experience with varying study types and phases (Phase III experience would be preferred)
- Proven competence in managing delivery of multiple projects/programs independently through full data management study life-cycle.
- Demonstrated strength and developed expertise in DM. A solid understanding of regulatory submissions, guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables
- Subject matter expertise for key DM related global process improvement initiatives
- Prior inspection and major (vendor) audit experience preferred
- Solid cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical and the ability to support studies across multiple phases of development
- Strong computer skills, including database management software (ie. Microsoft Access), reporting tools, medical coding tools, etc.
- Experience with EDC and ePRO systems/devices (specifically, Medidata) and the implementation of such systems
- Strong knowledge of medical terminology, including implementation and use of the WHODrug and MedDRA dictionaries
- In-depth knowledge of the drug development and data management processes
- Very good knowledge of international regulations for clinical trials (e.g. GCP) and familiar with CDASH/CDISC standards
- Ability to travel 25% of time
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.