Associate Director, Clinical Data Management

Location
New York City Metropolitan Area, New York, United States
Posted
Nov 13, 2020
Ref
2305829513
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
COMPANY

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's led investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).

POSITION

The Associate Director Data Manager partners with internal and external stakeholders to optimize Data Management of our clinical trial program, implement processes and standards, and ensure data quality.

RESPONSIBILITIES

• This individual will leverage their expertise to develop best practices for our clinical trials; proactively identify and manage risks and ensure timely delivery of the data ensuring quality data for DSMB, DSUR, interim analysis, database lock, TLFs, and final clinical study reports (CSR).

• Provides vendor oversight to ensure that the process, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with the study requirements, DMP, SOPs and GCPs.

• Responsible for all Data Management timelines and deliverables from study start up to final clinical study report.

• This position requires significant knowledge of Electronic Data Capture/related applications and industry standards, and significant skills in working with data received from CROs and other third-party vendors.

• He/She will plan/direct the conduct of Data Management activities for assigned projects/studies through outsourcing. Hands-on work is required.

• Additionally, this individual must possess advanced knowledge of clinical operations and relevant regulatory requirements.

• Work well with individuals cross-functionally and at all levels of the organization.

• He/She must possess excellent verbal/written skills, analytical, organizational, and interpersonal skills.

• Resolve and/or escalate issues encountered at the project/study and/or functional team level.

• Improves quality/inspection readiness, decreases cycle times, and reduces costs.

• Maintains awareness of Data Management emerging trends, technology and best practices and makes recommendations for regional improvements.

• Develops and maintains peer relationships with thought leaders in Data Management and related areas.

Education/Experience
  • BA or MS
  • 4+ years data management and/or related work experience in biotechnology, pharmaceutical company, or similar environment (e.g., CRO).


Ovid Therapeutics is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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