Sr. Clinical Data Manager

**Job description**

Innovent Biologics is an international biotech organization with one primary focus: to develop high quality biopharmaceuticals available to all people. Since our beginning in 2011, Innovent has launched 4 biologics products in the Chinese market with the goal to expand and continue development in partnership with major providers in the US and across the globe. Innovent continues to push the limits of development with trials in various stages and a robust pre-clinical pipeline covering diverse disease indications. Here at our lab site in Rockville, Maryland, we are looking to have talented and passionate team members join us on our exciting journey of innovation and discovery, changing lives one patient at a time.

**General Summary**

We are currently seeking a full time Senior Clinical Data Manager to join Innovent Biologic team. This Senior Clinical Data Manager manages all aspects of clinical data management for assigned project(s). This includes CRF/eCRF design, database development, development of validation strategy, discrepancy management, database release, extraction, and reporting of data during study conduct, review of data before database lock, review of clinical study reports. This position will work with clinical operation, clinical development, biostatistician, programming, CROs and other service providers to assure quality within the data management life cycle.

**Principal Duties and Responsibilities**
- Participate in review of clinical study protocols and statistical analysis plans to ensure clinical data capture is complete, consistent, and accurate for data analyses
- Design and Implementation of CRFs in the database and assuring that the database for each study is live in a timely manner
- Direct 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, and data transfer specification, as well as other aspects of data collection and management in the contest of clinical development
- Lead study team data quality review activities
- Generate, resolve, and track data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications
- Generate routine tracking/reporting of study metrics, creating tools/reports to aid in study management
- Identify and resolve potential data quality related trending/issues, in coordination with study team and external vendors
- Lead data locking activities, ensuring that study team members have executed accordingly the DMP toward the goal of achieving analysis-ready datasets
- Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File
- Collaborate with the team while developing and implementing data standards and SOPs
- Other duties as assigned
Education
- Bachelor’s Degree in Computer Science or related field
Experience
- 5-7 years of progressively more challenging work experience in Clinical Data Management, Oncology or Ophthalmology experience preferred
Knowledge, Skills, and Abilities
- Knowledge of clinical research process and methodology
- Flexibility and ability to manage multiple priorities simultaneously
- Excellent verbal and written communication skills
- Meticulous attention to details
- Hands-on experience on study start-up, database cleaning, lock, and closeout activities
- Knowledge of CDASH standard and SDTM mapping
- Knowledge of regulatory requirements and information governance frameworks (e.g., ICH, GCP, GDPR)
- Excellent team player with demonstrated track record of success in a cross-functional team environment
- Consistent commitment to delivering on team goals with a sense of shared urgency
- Experience working on studier under the purview of the FDA and EU regulatory agencies is a plus
- Familiarity with various data visualization, analytics and reporting tools
- Must have proficiency in Excel, Electronic Data Capture Systems (experience with TrialMaster system is a plus)
- Ability to learn other software quickly
**Physical and Mental Requirements**
- Sit or stand for extended periods of time at stationary workstation
- Regularly carry, raise, and lower objects of up to 25 Lbs
- Focus and attention to tasks and responsibilities
- Verbal communication, listening, understanding, responding, and speaking
- Limited travel as needed
**EEO Statement**

Innovent provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these ch