Experience: 5 – 10 plus years’ relevant experience in CLINICAL DATA MANAGEMENT
Qualification: B Pharm/ M pharm/ Pharm D/ BHMS/ BAMS/ Any life science background
SALARY : Competitive salary with career advancement opportunities.
LOCATION : USA / East Coast / Remote
Primary responsibilities:
Involvement in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
Take a leadership role with SRP/SRS to establish, align and confirm complex scientific clinical data review expectations for assigned trial(s).
With the SRP/SRS, CRO and other functional partners in relation to CDM related activities:
Review content for Electronic Code of Federal Regulations (eCRF) and other data collection tools.
Establish conventions and quality expectations for clinical data.
Set timelines and follow-up regularly to ensure delivery of all relevant Data Management milestones.
Identify and communicate ways to improve deliverables.
Review complex scientific clinical study data, manages CDM and SRP/SRS related queries in Electronic Data Capture (EDC) system and collaborate with SRP/SRS. Involvement in other review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation).
Lead and/or attend meetings, as appropriate.
Create the trial level or disease area Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Review related clinical data management documents. Ensure compliance with regulatory guidelines and documentation requirements.
Ensure real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary.
Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
Identify and participate in process, system, and tool improvement initiatives within Data Management.
Lead or participate, depending on the complexity of the project, in implementing process, system, and tool improvement initiatives within CDM.
Experience: 5 - 10 years’ relevant experience in Pharmacovigilance
Qualification: B Pharm/ M pharm/ Pharm D/ BHMS/ BAMS/Any life science background
SALARY : Competitive salary with career advancement opportunities.
LOCATION : USA / East Coast / Remote
Primary responsibilities:
Confirm validity of case by identifying minimum criteria for case creation.
Perform duplicate search to create either an initial case or a follow-up case.
Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports.
Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases.
Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case.
Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file.
Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA.
Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements.
SALARY : Competitive salary with career advancement opportunities.
LOCATION : USA / East Coast / Remote
ROLE/DESCRIPTION:
Confirm validity of case by identifying minimum criteria for case creation.
Perform duplicate search to create either an initial case or a follow-up case.
Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports
Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases.
Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case.
Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file.
Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA.
Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements.
Draft narratives
Competent in written and oral English.
Good communication skills.
REQUIREMENTS:
Master’s degree with 8 years and Bachelor's degree with 10 years in Applied Science, Life Science and Engineering.
Eight plus years’ experience in Statistical / Clinical SAS Programming.
At least 5 years oversite and leading a study.
Very Strong CDISC knowledge
Design of clinical trials or clinical experiments, basic medical terminology and processing clinical trial information
Develop, validate, and maintain programs for the analysis and reporting of clinical trial data using programming languages such as SAS and R.
Collaborate with cross-functional teams to understand programming requirements and project timelines.
Communicate effectively with team members, sharing insights and updates on statistical programming activities.
Implement and adhere to programming standards and best practices to ensure accurate and reliable statistical analyses.
Unparalleled communication skills and the ability to lead/influence others.
SALARY : Competitive salary with career advancement opportunities.
LOCATION : USA / East Coast / Remote
ROLE/DESCRIPTION:
You will be the 'go to' person for providing timely support to the study teams on all programming matters according to the project strategies.
Develop, validate, and maintain programs for the analysis and reporting of clinical trial data using programming languages such as SAS and R.
Collaborate with cross-functional teams to understand programming requirements and project timelines.
You will provide strategic statistical programming planning and execution, including data transformation, data analysis and data reporting.
As the Statistical Programmer, you will provide high level support to the clinical development teams and collaborate closely with scientists and experts.
This includes leading study and oversight of statistical programming in complex phase I-IV clinical trials or projects.
Develop robust programming specifications for internal and external programming work.
Support development and validation of e-submission requirements.
Competent in written and oral English.
Good communication skills.
REQUIREMENTS:
At least 8+ years Clinical SAS Programming experience.
Bachelor's degree in an applied Science or Life Science discipline or Engineering.
At least 1 years oversite and Leading a study.
Very Strong CDISC knowledge.
Design of clinical trials or clinical experiments, basic medical terminology and processing clinical trial information.
Expert knowledge in SAS/Macro, Proc Report.
Knowledge of regulatory requirements and industry standards for statistical programming in clinical trials.
Experience in standards/SOP development is a plus
Unparalleled communication skills and the ability to lead/influence others.
Job Description: Statistical / Clinical Programmer III
JOB ID: 1053
SALARY : Competitive salary with career advancement opportunities.
LOCATION : USA / East Coast / Remote
ROLE/DESCRIPTION:
You will be the 'go to' person for providing timely support to the study teams on all programming matters according to the project strategies.
You will provide strategic statistical programming planning and execution, including data transformation, data analysis and data reporting.
Ensure compliance with regulatory requirements and industry standards for statistical programming in clinical trials.
Perform Sponsor oversight of the programming activities for the outsources clinical trials, including datasets (SDTM/ADAM) programming.
Contribute to the set-up and development of the in-house data analyses and data storage systems.
As the Statistical Programmer, you will provide high level support to the clinical development teams and collaborate closely with scientists and experts.
This includes leading study and oversight of statistical programming in complex phase I-IV clinical trials or projects.
Develop robust programming specifications for internal and external programming work.
Support development and validation of e-submission requirements.
Competent in written and oral English.
Good communication skills.
REQUIREMENTS:
At least 8+ years Clinical SAS Programming experience.
Bachelor's degree in an applied Science or Life Science discipline or Engineering.
At least experience in oversite and leading a one study.
Very Strong CDISC knowledge.
Design of clinical trials or clinical experiments, basic medical terminology and processing clinical trial information.
Expert knowledge in SAS/Macro, Proc Report, and ODS.
Unparalleled communication skills and the ability to lead/influence others.
