Assoc. Spclst, Clinical Data Mgmt; Hybrid

Position: Assoc. Spclst, Clinical Data Mgmt (Hybrid)
** Job Description*
* *
* Position Overview:

*
* Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our Company's Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

** Primary activities include, but are not limited to:*
* + Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM

+ Runs data integrity check reports in accordance with data review plans and relevant SOPs.

+ Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.

+ Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.

+ Escalates overdue items, including but not limited to outstanding questions and missing visits.

+ Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.

+ Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.

+ Maintains compliance with standard key performance indicators according to process expectations at the protocol level.

+ Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.

+ Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.

** Qualifications,

Skills & Experience:

*
* + High School Diploma (or equivalent).

+ Preferred B.A. or B.S. degree, in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

** Knowledge and

Skills:

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* + Self-motivated, excellent in work planning and time management.

+ Fluent oral and written English skills.

+ Good sense and awareness of regulations and policies.

+ Able to work under pressure and in a changing environment with flexibility.

+ Good communication skills with the ability to communicate with both the technical and business areas.

MSJR

GDMS

clinicaltrialjobs

eligibleforERP

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* Required Skills:

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* Adaptability, Analytical Problem Solving, Clinical Data Cleaning, Clinical Data Management, Communication, Data Analysis, Data Documentation, Data Entry, Data Processing, Data Quality, Data Reporting, Data Review, Data Validation, Data Visualization, Good Clinical Practice (GCP), Root Cause Analysis (RCA), Teamwork

** Preferred

Skills:

*
* Adobe Acrobat, Adobe Forms, Adobe Sign, Microsoft Applications, Microsoft Excel, Microsoft Office, Microsoft Windows, VLOOKUP Function

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.  

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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

EEOC GINA Supplement​

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