Associate Director, Data Management
Summary of Position
The Associate Director, Data Management collaborates closely with counterparts in Clinical Operations and in Translational Sciences to ensure excellent operational oversight of clinical studies. The Associate Director, Data Management interfaces effectively with the study DM vendor and the Amicus study team to plan, manage and ensure execution of all tasks from protocol design to final CSR, to produce high-quality study data and to achieve corporate goals on time and on budget.
Roles and Responsibilities
Coach and mentor all staff under him/her; set objectives, solicit 360 feedback from stakeholders and conduct performance reviews to foster growth of staff.
Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives.
Ownership of clinical study databases.
Accountable for database integrity and accuracy.
Oversee data management activities at vendor from CRF/database development through database lock.
Collaborate with study team during protocol development with the mindset of "start with the end in mind" to ensure the operational team is poised for successful data to enable the program strategy.
Lead all DM activities including data collection forms (CRFs, diaries and CRF completion guidelines), clinical databases, study related data management documents, SOPs, etc.
Work closely with Translational Sciences during study start-up to ensure Central Lab database is designed and programmed appropriately.
Adhere to FDA regulations (21 CFR Part 11, GCP), ICH guidelines and internal SOPs.
Lead oversight of quality data and timeliness of all deliverables from DM vendor
Ensure the completeness, accuracy and consistency of data so that they meet the standards of quality expected for reporting to regulatory bodies.
Interface with CRAs and other Clinical Operations team members to ensure the quality of data collection.
Lead data transfers agreements with 3rd party labs to ensure the appropriate formatting, conversion and transfer of external data .
Communicate regularly with other team members to report and resolve issues
Track data management performance.
BS or BA in relevant field required
Minimum of 5 years of clinical data management experience, including database set-up, data validation and consistency checks, initiation and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data, coding, and SAE reconciliation or equivalent
Proficient in the use of clinical data management systems, including paper based and EDC systems, IVRS systems, and online enrollment
Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
Excellent written and oral communication skills, including experience with production of requirements documents, technical specifications, and other components of a clinical study database development process
Knowledge of clinical data acquisition standards harmonization (CDASH), experience with SAS programming or relational databases a plus
Proficient in the use of data management tools
Self-motivated and able to function with little supervision
Excellent interpersonal skills
Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management
Good team player
Able to resolve conflicts in a diplomatic manner
Demonstrated leadership skills
Ability to manage up and down
Good negotiation skills
Solid problem-solving and decision-making skills
Amicus Therapeutics, Inc.