Associate Director, Clinical Data Management
Alkahest is seeking an Associate Director, Clinical Data Management reporting to the VP Clinical Development, to manage all aspects of clinical data management for assigned project(s). This includes CRF/eCRF design, database development, validation programming, discrepancy management, database release, extraction and graphical representation of safety data during study conduct, review of data before database lock, review of CSRs. This position will work with Clinical Operations, project teams, CROs and other service providers to assure quality within the data management life cycle.
- Demonstrated ability to work on complex technical problems providing innovative solutions. Exercises good judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for data processing that leads to high quality results.
- Directs the development, management, and execution of the study Data Management Plan (DMP) which includes the data collection strategy and User Acceptance Testing (UAT), Case Report Form (CRF) design, CRF completion guidelines, SAS annotated CRFs, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plans, as well as other aspects of data collection and management in the context of clinical development.
- Participates in review of clinical protocols and amendments and uses knowledge of protocol to coordinate the design and testing of data capture systems.
- Leads review teams to review data quality reports. Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications. Identifies and resolves data management issues, in coordination with other departments and contract data management groups, as appropriate. Directs the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines and budget.
- Uses the appropriate software to coordinate completion of various duties, including data transfers and quality reviews of the database, database lock and release, archival of data management documentation and files, and coordination of coding for the adverse event and medication dictionaries.
- Works with Clinical, Biostatistics, Regulatory and project teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP).
- Leads new data management initiatives such as establishing capacity for electronic data capture. Oversees CRO data management functions and conducts/supervises inspections and audits as appropriate.
- Contributes to the development and implementation of departmental policies, standards and process improvement initiatives.
KNOWLEDGE AND EXPERIENCE
- Bachelor/Master’s degree or equivalent.
- A minimum 5 years pharmaceutical development experience with at least with at least 3 years of progressive experience in clinical data management; managing this function in CROs is required.
- Advanced knowledge of Data Management processes and systems, including Electronic Data Capture (EDC).
- Knowledge of Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines is required.
- Experience and understanding of ICH and GCP is required as well as understanding of the clinical drug development process
- Must have strong computer system validation skills with a proficiency in Microsoft applications (Word, Excel), programming languages/tools (e.g. J-Review, SpotFire, SAS, Java, C++), and relational databases (SQL, PL/SQL, etc.).
- Must have demonstrated problem solving abilities and strong organizational skills.
- Must be a demonstrated self-starter but also able to work well with teams and have strong interpersonal and communication skills.