- 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.
- 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.
- BS or BA in relevant field required or lesser degree with 10+ years' experience
- 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.
- Highly detail-oriented
- 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
- Demonstrate alignment with Amicus Mission Focus Behaviors
- Passion for Rare disease and patient focused.
- It is expected that any remote worker be able to travel to the office up to 10% of the time.
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Associate Director, Clinical Data Management - Princeton, United States - Amicus Therapeutics, Inc.
1 week ago
Description
Associate Director, Clinical Data Management
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
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 ResponsibilitiesThe Associate Director Data Management is responsible for:
Ownership of clinical study databases.
Educational Requirements
Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority.
Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.Our "Three Pillars of DEI" are interwoven into our Amicus culture and expands one person, one word, and one act at a time.
For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
