Current Job Openings

TITLE: SR. CLINICAL DATA MANAGER

REQUIREMENTS: Master’s degree in Pharmacology + Toxicology, Statistics with 2 years of experience in a job title with similar duties and skills.

DUTIES: Create and/or review clinical data management documentation, including but not limited to the study protocol, data management plan, clinical data review plan, data transfer agreements, CRF Completion Guidelines, and data issue logs, and ensure all study activities are conducted; Create and review eCRF specifications, Edit Check specifications, Query logic, Dynamic logic, and UAT test scripts to ensure clinical data is collected and reviewed; Manage manual data listings, reviews, metrics, outstanding issues, and generate manual queries in the software, which includes Medidata Classic Rave, Medidata RaveX, Oracle Inform, and IBM Clinical, to ensure all the data entered is cleaned; Integrate operations of clinical data management with requirements of Clinical, Project management, Biostatistical, medical, and Safety departments regarding project status and issues; Monitor Clinical data to ensure clinical trials are conducted as per ICH/GCP guidelines; Experience in CDASH, CDISC, 21 CFR Part 11, and GCDMP; Skills- Medidata Classic Rave, Medidata RaveX, Oracle Inform, IBM Clinical, Edit Check specifications, Query logic, Dynamic logic, & UAT test scripts. Must be willing to travel and/or relocate to work in various worksites throughout the US. No telecommuting. Send resume to Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.

SALARY: $109, 262.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

JOB LOCATION: Nexpro Technologies Inc 114 Crockett Rd, King of Prussia, PA 19406

CONTACT: Srivinas Rao B, HR Manager

Phone: 610-590-4284


Title: SR. SAS SPECIALIST PROGRAMMER

REQUIREMENTS:Master’s degree in Data Analytics, Data Science with 1 year experience in a job title with similar duties and skills.

DUTIES:

Experience in annotate blank CRF & review annotated CRF (aCRF); Create & review specifications for both tabulation datasets (SDTM) & analysis datasets (ADaM) by referring to various study documents like the aCRF, protocol, SAP, raw datasets, etc.; Ensure consistency of data flow from case report forms (CRFs) to specifications for tabulation (SDTM) datasets and analysis datasets (ADaM); Extract data from database & involve in cleaning data & deleting duplicates using various editing techniques; Work with data management team to address any data issues; Program for statistical analysis (via tabulation datasets (SDTM), analysis datasets (ADaM), tables, figures, listings (TLFs), etc.) using a Statistical Analysis Software tool (SAS); Create define.xml file & participate in validation & review; Create submission documents to the FDA by supporting creation of study data reviewers guide (SDRG), analysis data reviewers guide (ADRG), & electronic submission packages. Skills: CRF, SDTM, ADaM, SAS, SAP, ADRG, &.xml. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting. Send resume to Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.

SALARY: $99,965.00/Year

Job Location: Nexpro Technologies Inc 114 Crockett Rd, King of Prussia, PA 19406

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

Phone: 610-590-4284


Title: SR. CLINICAL DATA MANAGER

REQUIREMENTS:Master’s degree in Healthcare Informatics, Health Services Administration with 6 months of experience in a job title with similar duties and skills.

Job Location: Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.

DUTIES:

Support development, evaluation, and validation of CRFs for clinical databases using Medidata Rave, Medrio, Clario EDC, and Inform; Perform all user acceptance testing (UAT) duties pertaining to clinical research databases, such as but not limited to test script approval facilitation, test script execution, and test script evaluation; Estimate and forecast costs for data management tasks while accounting for factors such as data volume, complexity, data cleaning efforts, system maintenance, and any specific data requirements for regulatory compliance; Estimate costs for data management resources using Electronic Data Capture (EDC), Python, SAS EG; Facilitate cross-functional interactions between clinical data management, clinical operations, clinical development, bio statistics, medical affairs, clinical programming, and IT to ensure that the necessary data is captured using the EDC systems. Skills- Medidata Rave, Medrio, Clario EDC, Inform, Python & SAS EG. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No telecommuting. Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.

SALARY: $109, 262.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

CONTACT: Srivinas Rao B, HR Manager

Phone: 610-590-4284


Title: Sr. Clinical Data Manager

REQUIREMENTS: Master’s degree in Public Administration, Health Administration with 1 year experience.

Job Location: 114 Crockett Rd, King of Prussia, PA 19406

PRE REQUISITES:

  • Conduct clinical data management activities for oncology clinical trials in accordance with clinical Practices (GCPs) guidelines and company Standard Operating Procedure (SOPs)
  • Review clinical research study protocols & design of clinical database structure and case report forms (CRFs) consistent with Clinical Data Interchange Standards Consortium (CDISC) and Clinical Data Acquisition Standards Harmonization (CDASH) Guidelines.
  • Develop edit check specifications, test plan, test scripts, and perform User Acceptance Testing (UAT) of clinical data base. Execute documents such as clinical data management plans, guidelines for CRF completion, Reconciliation of Serious Adverse Events, Trial master file (TMF) plans & data audits.
  • Develop data transfer agreements and specifications for data sources (Central labs, biomarkers, Electrocardiogram, CT/MRI Imaging etc.)
  • Review clinical data, data listings and patient profiles for data consistency. Compile clinical data for regulatory submissions like Biologics License Application (BLA), New Drug Application (NDA) to U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA) and Pharmaceutical and Medical Device Agencies (PMDA).

Skills: CDISC, CDASH, edit check & UAT.

Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting. Send resume to Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.