Clinical Data ​Manager

[Primary ​Responsibilities]

Portfolio ​Strategy, Planning ​and Delivery

- Ensure that ​data ​management timeline ​and results are ​delivered to ​scope, ​cost and ​time ​objectives, ​especially synchronize deliverables ​with ​the overall study ​timelines

- ​Perform ​project monitoring and ​quality oversight ​of ​sourcing providers ​for end-to-end ​data ​management activities - ​from study ​set up through trial execution through dataset delivery

- Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, biomarker)

- Drive data flow design through consultation, review, and approval of vendor work. Ensure the data flow design is aligned with the project hypothesis

- Approve key outputs and results (i.e. Data Quality Delivery Plan, Data Lock Plan, Project Plan, Database and observed datasets)

- Define and approve data quality and submission outputs and results

Project Management

- Lead all aspects of the data management lifecycle activities from the development of project documentation, study/system start-up, User Acceptance Testing (UAT), maintenance including routine data review, database lock and close-out with minimal guidance.

- Ensure vendor management in terms of data management related activities and that data acquisition, database design, and observed dataset requirements are reflective of specific protocol

objectives

- Specify the data collection tools and technology platforms for the trial/program

- Drive standards decisions, implementation and compliance for the study/program

- Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios

- Facilitate/assimilate integration of disparate data sources into datasets for decision making

- Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate

- Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations to data deliverables

Communication

- Act as primary communication point for all data management activities related to clinical studies

- Ability to work cross-functionally and understanding of independently collaborating with different teams to lead data management activities

- Report out status of data management milestones and data quality

- Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database

- Demonstrate excellent written and verbal communication skills, including the ability to represent the data and analytics functional group and influence stakeholders to drive data-driven decisions.

- Partner with cross-functional team members to ensure trial success through robust oversight/review.

Process Improvement

- Continually seek and implement means of improving processes to reduce cycle time and decrease work effort

- Represent data sciences' processes in multi-functional initiatives

- Actively engage in shared learning across the team

- Work with partners to increase vendor/partner efficiencies

[Minimum Qualification Requirement]

- Degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences

- At least 5 years of experience working as a clinical data manager at a sponsor or CRO

[Other Information/Additional Preferences]

- Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities

- Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results

- Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles

- Demonstrated ability to lead development of creative data solutions to address clinical development challenges

- Passionate about improving technological solutions using new technologies

- Society of Clinical Data Management certification

- Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, 'R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS

- Able to work flexible hours considering the time zone differences across Asia and the US

- Applicants who are eligible to work in Europe are preferred.

Experience with the following:

- Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions

- Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members

- Strong therapeutic/scientific knowledge in the field of research

- Knowledge of medical terminology

- Domestic and international travel may be required

- Ability to balance multiple activities, prioritize and manage ambiguity

- Demonstrated exemplary teamwork/interpersonal skills

- Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment