Associate Director, Data Management job in Cranbury
Vacancy has expired
|Employer:|| Amicus Therapeutics|
|State:||New Jersey (NJ)|
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.