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||Princeton, NJ United States
|| Biotechnology and Pharmaceutical
Manager Clinical Data Management|
Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Project Data Manager (PDM) coordinates assigned clincial data management activities for clinical studies and represents Data Management as the primary point of contact with clients and internal members of the study team.
Serve as Clinical Data Management Lead on all assigned projects and activities.
Develop study specific eSource or electronic Case Report Forms (eCRF), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection.
Responsible for clinical database management, data verification, data cleaning, and quality assurance of multiple projects.
Provide strategic input into protocol design and ensure protocol can be operationalized from a data management perspective.
Represent Data Management on project teams as needed.
Ensure timely completeness and accuracy of databases.
Attend/conduct meetings, teleconferences and webinars relevant to current or upcoming projects.
Provide status reports on the progress of projects to study team.
Create and maintain data management documents per SOP (e.g. Data Management Plan, User Acceptance Testing Plan, Edit specifications, CRF Completion Guidelines, etc.).
Ensure data management related presentations for Investigator's meetings adhere to Otsuka requirements.
Oversee the Contract Research Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global Otsuka standards.
Work collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues for outsourced studies.
Adhere to DM standards and processes for both in-house and CRO studies in accordance with Good Clinical Practices (GCP).
Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes and ensure compliance.
Manage third party vendors (e.g., CROs) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.
Maintain a thorough understanding of regulatory requirements for clinical trials.
Proactively identify and implement opportunities for process improvements.
Other tasks/deliverables as assigned.
Qualifications/ Required Knowledge/ Experience and Skills:
Strong understanding of clinical medical concepts and terminology.
Knowledge of Guidelines for GCP, 21 CFR Part 11 regulations, and Regulatory requirements for clinical trials.
Strong working knowledge of data management processes and applicable global regulatory requirements.
Demonstrated ability to prioritize multiple projects and deliverables.
High attention to detail, ability to multi-task and be collaborative.
Strong computer skills with demonstrated experience in Microsoft Office Software.
Oral and written communication/presentation skills.
Bachelor's degree with a minimum of 4 years of experience in pharmaceutical industry.
Basic understanding of clinical development and data management processes; or equivalent combination of education and experience.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
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