Clinical Programming Manager
Clinical Programming Manager
Posted on :
19-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
19-08-2025
Job Description
Position Details:
Our client a world-leading Pharmaceutical Company in West Chester PA is currently looking for an Clinical Data Manager to join their expanding team.
Job Title: Clinical Data Manager (SDTMIG Pinnacle 21) / REMOTE WORK
Duration: 24 months contract
Location: West Chester PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Experience Required:
Functional Knowledge:
Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis.
Our client a world-leading Pharmaceutical Company in West Chester PA is currently looking for an Clinical Data Manager to join their expanding team.
Job Title: Clinical Data Manager (SDTMIG Pinnacle 21) / REMOTE WORK
Duration: 24 months contract
Location: West Chester PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Temp to Perm:
Not at this time
Not at this time
Shift Schedule:
Morning - US time zone 8 hours/day preferably East Coast
Morning - US time zone 8 hours/day preferably East Coast
Core essential skill sets candidates must have to be considered for the role:
1. Minimal Bachelors degree in any field
2. Minimal 5 years experience with Clinical data SDTM IG and Pinnacle 21.
1. Minimal Bachelors degree in any field
2. Minimal 5 years experience with Clinical data SDTM IG and Pinnacle 21.
Position Summary:
The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Manager leads and manages completed projects that involve global tasks cross functional teams or outsourcing resources.
The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Manager leads and manages completed projects that involve global tasks cross functional teams or outsourcing resources.
The role may require providing input to design and analysis and report the results of clinical trials including programming rules and mocked T/L/G. In addition providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
Travel Requirements:
Limited as job tasks are required
Limited as job tasks are required
Essential Duties & Responsibilities:
1. Provides input for Budget Planning
2. Likely to oversee contingent workers and/or vendors; Likely to provide training to others
3. Primarily works at the project level
4. Delivers assignments with quality and within timelines
5. Contributes strategy under moderate supervision
6. Provides strong programming support to CDISC based e-submission. Develop review and/or perform validation of generic macros. Develop debug and enhance SAS programs to support quality control of safety or efficacy derived datasets
7. Has good knowledge and understanding of the statistical models in efficacy data analysis
8. Responsible for the standardization of Clinical Programming deliverables within a project
9. Extends existing or develops new clinical programming methods to solve complex problems
1. Provides input for Budget Planning
2. Likely to oversee contingent workers and/or vendors; Likely to provide training to others
3. Primarily works at the project level
4. Delivers assignments with quality and within timelines
5. Contributes strategy under moderate supervision
6. Provides strong programming support to CDISC based e-submission. Develop review and/or perform validation of generic macros. Develop debug and enhance SAS programs to support quality control of safety or efficacy derived datasets
7. Has good knowledge and understanding of the statistical models in efficacy data analysis
8. Responsible for the standardization of Clinical Programming deliverables within a project
9. Extends existing or develops new clinical programming methods to solve complex problems
Position Requirements:
Education Required:
Education Required:
Bachelors Degree/ Masters Degree/ PhD in Science Statistics Information Technology or equivalent combination of education and related work experience.
Experience Required:
Bachelors 5 years or Masters 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
Experience Preferred:
Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
Specialized or Technical Knowledge Licenses Certifications needed:
Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
Specialized or Technical Knowledge Licenses Certifications needed:
Functional Knowledge:
Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis.
Company/Industry Related Knowledge: Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.
Job-Specific Competencies:
1. Contributes to strategy under moderate supervision
2. Tackles difficult problems; identifies solutions and recommends action to management
3. Influences communication toward common understanding and actionable results; contributes to process and development
4. Ability to effectively work in a global environment
5. Ability to effectively interact with and influence others without direct reporting relationships
1. Contributes to strategy under moderate supervision
2. Tackles difficult problems; identifies solutions and recommends action to management
3. Influences communication toward common understanding and actionable results; contributes to process and development
4. Ability to effectively work in a global environment
5. Ability to effectively interact with and influence others without direct reporting relationships
Employment Type
Full-time
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