Theradex Systems, Inc.
Clinical Data Manager/Senior Clinical Data Manager
Theradex Systems, Inc., Princeton, New Jersey, us, 08543
Theradex Systems, Inc.
Theradex is an Equal Opportunity Employer.
US-NJ-Princeton | US
ID
2025-1410
Category
Clinical Data Management
Type
Full Time
Who We Are Celebrating 40+ years!
Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.
What You'll Do Remote-US Preference will be given to candidates located in the tri-state area (commutable to Princeton, NJ)
As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.
Opportunity
Clinical Data Manager/Sr Clinical Data Manager - dependent upon experience
You will play a pivotal role in ensuring the integrity and quality of our clinical trial data. You will collaborate closely with cross-functional teams and manage data management activities for multiple studies.
The primary responsibilities of this position include, but are not limited to, the following:
Perform all clinical data management activities in compliance with SOPs and ICH-GCP regulatory requirements
Work closely and collaboratively with the SAS Programming team, biostatistics team and other data managers
Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision
Serves as the main point of contact for study DM related matters
Lead DM Study Start-Up Activities
Conduct
EDC
User Acceptance Testing and program validations.
Develop programs in
SAS/EXCEL
for study data metrics monitoring and clinical data review.
Perform comprehensive data review of all patient data.
Perform
WHO Drug Dictionary coding
and
MedDRA coding
as necessary
Support Project Team through:
Tracking and provision of project status updates to project managers for monthly project team meetings
Close communication with CRA's to identify and mitigate negative data trends/issues
Provision of listings/reports as needed
Create ad-hoc reports for special data requests from Sponsor
Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
Coordinate all activities in preparation for study milestones and database lock
May assist in the mentoring of less experienced employees
Manage and prioritize project deliverables per established study timelines
What You Need Level of Education and Prior Experience
Bachelor's degree required / Master's degree preferred
3-5 Years relevant data management experience in the CRO / pharmaceutical industry required
EDC
experience required,
RAVE EDC
experience preferred
SQL/SAS
programming experience preferred
Skills and Competencies
Demonstrates knowledge of
GCP s and protocol
Strong understanding of
CDISC CDASH and SDTM Standards
Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
Excellent interpersonal skills
Fluent knowledge of written and verbal English
Highly organized and result-oriented
Strong communication, comprehension and logic skills
Ability to work independently with minimal supervision as well as in a team environment
Proficient in Word and Excel
Ability to understand high level programming languages
Strong time management and prioritization skills to meet deadlines among multiple projects
What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-$150,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for relocation or company provided sponsorship.
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Theradex is an Equal Opportunity Employer.
US-NJ-Princeton | US
ID
2025-1410
Category
Clinical Data Management
Type
Full Time
Who We Are Celebrating 40+ years!
Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.
What You'll Do Remote-US Preference will be given to candidates located in the tri-state area (commutable to Princeton, NJ)
As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.
Opportunity
Clinical Data Manager/Sr Clinical Data Manager - dependent upon experience
You will play a pivotal role in ensuring the integrity and quality of our clinical trial data. You will collaborate closely with cross-functional teams and manage data management activities for multiple studies.
The primary responsibilities of this position include, but are not limited to, the following:
Perform all clinical data management activities in compliance with SOPs and ICH-GCP regulatory requirements
Work closely and collaboratively with the SAS Programming team, biostatistics team and other data managers
Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision
Serves as the main point of contact for study DM related matters
Lead DM Study Start-Up Activities
Conduct
EDC
User Acceptance Testing and program validations.
Develop programs in
SAS/EXCEL
for study data metrics monitoring and clinical data review.
Perform comprehensive data review of all patient data.
Perform
WHO Drug Dictionary coding
and
MedDRA coding
as necessary
Support Project Team through:
Tracking and provision of project status updates to project managers for monthly project team meetings
Close communication with CRA's to identify and mitigate negative data trends/issues
Provision of listings/reports as needed
Create ad-hoc reports for special data requests from Sponsor
Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
Coordinate all activities in preparation for study milestones and database lock
May assist in the mentoring of less experienced employees
Manage and prioritize project deliverables per established study timelines
What You Need Level of Education and Prior Experience
Bachelor's degree required / Master's degree preferred
3-5 Years relevant data management experience in the CRO / pharmaceutical industry required
EDC
experience required,
RAVE EDC
experience preferred
SQL/SAS
programming experience preferred
Skills and Competencies
Demonstrates knowledge of
GCP s and protocol
Strong understanding of
CDISC CDASH and SDTM Standards
Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
Excellent interpersonal skills
Fluent knowledge of written and verbal English
Highly organized and result-oriented
Strong communication, comprehension and logic skills
Ability to work independently with minimal supervision as well as in a team environment
Proficient in Word and Excel
Ability to understand high level programming languages
Strong time management and prioritization skills to meet deadlines among multiple projects
What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-$150,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for relocation or company provided sponsorship.
#J-18808-Ljbffr