Position Title: (Associate) Manager, Data Management
Function: Clinical Development
Entity: Laekna Therapeutics
This position will provide DM leadership across assigned trial(s) in collaboration with project team members and vendors. You will play an important role in coordinating and overseeing on Data Management (DM) operational activities and deliverables, performing data integrity review, providing expertise and advice on data acquisition and management, ensuring compliance with the corporate timeline and scope of work outsourced to the CDM vendor and coordinating activities from other external vendors that may also provide study data.
1.Coordinate the Clinical Data management deliverables on assigned projects and maintains oversight of the day-to-day operational aspects of CDM for assigned projects; Responsible to identify risks and collaborate with the CDM Vendor to mitigate the risk.
2.Oversees vendor timelines and milestone deliverables for the assigned projects and work with CDM vendor to ensure deliverables are on time. Track content, format, quality, and timing of data management deliverables, including but not limited to, CRF, data review plan, oversight plan, database release and lock plan, final data delivery, submission and archival.
3.Communicates and collaborates effectively with all project level team members. Primary point of contact for CDM vendor and provides guidance and supervision at the project level.
4.Understands therapeutic area, indication or program specific data capture standards.
5.Offer guidance and advice to peers within the function, key stakeholders, CRO and collaborative groups on technical solutions to ensure high quality data collection and delivery. Enable broader and more effective use of data to support the business. Deliver on solutions as needed.
6.Responsible for compliance to Trial Master File requirements relating to CDM Vendor.
7.Support on SOPs development to receive high quality of data from CROs and ensure compliance with applicable pharma industry regulations and standards.
1.BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or Pharmacy, Epidemiology, Preventive Medicine etc.
2.3-5 years of experience in clinical data management; Solid knowledge of Clinical Data Management process and applications, and electronic data capture (EDC).
3.Oncology experience preferred.
4.Excellent communication skills in Mandarin and English (written and verbal).
5.Knowledge of CDISC data standards and ICH-GCP.
6.Able to manage multiple requests and priorities.
7.Ability to collaborate effectively with stakeholders.
Laekna Therapeutics is an equal opportunity/affirmative action employer. All 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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