Associate Specialist, Clinical Data Management

** Job Description*
* Primary activities include, but are not limited to:

Assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.

Coordinates and participates in the following activities:

+ Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.  Review the technical feasibility of study team proposed programming/reporting and technically implements them. Work effectively among   team to communicate issues and ideas to improve the business along with understanding of Protocol .

+ Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.

+ Perform ongoing support for In-Life Reports.  Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.

+ ​Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

Education:

+ B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.

Knowledge and

Skills:

+ Expected to have a good technical proficiency in a Clinical Data Management/Reporting Systems like Power

BI or SQL/PL SQL or Databricks or Python or SAS, etc along with AI related tools.

+ Solid knowledge of MS Windows/Office software and exposure to web-based applications.

+ Solid knowledge of System Development Lifecycle Management / system validation knowledge

+ Ability to establish and maintain good working relationships with different functional areas.

+ Strong sense of urgency and customer focus.

+ Possesses excellent communication skills and interacts effectively with Study Team aling with Strong organizational and problem-solving skills.

+ Desire and ability to learn new processes and technologies

+ Ability to multi-task, work independently, and good communication skills

+ Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH

clinicaltrialjobs

EligibleforERP

GDMS

MSJR

*
* Required Skills:

*
* Adaptability, Adaptability, Analytical Problem Solving, Clinical Data Cleaning, Clinical Data Management, Clinical Medicine, Clinical Physiology, Clinical Reporting, Clinical Research, Computer Science, Data Analysis, Data Documentation, Data Entry, Data Processing, Data Reporting, Data Review, Data Validation, Data Visualization, Drug Discovery Process, FDA Regulations, Good Clinical Practice (GCP), Medical Review, Nephrology, Pathophysiology, Root Cause Analysis (RCA) {+ 2 more}

** Preferred

Skills:

*
* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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EEOC Know Your Rights (https://(Use the "Apply for this Job" box below). EEOC Know Your Rights  10 20.pdf)

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