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Responsibilities For This Role Are As Follows

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary.
• Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required.
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
• Receives and enters lab normal ranges.
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management
• Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
• For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.
• For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
• For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document
• Control Room per the Data Tracking Guidelines for the assigned projects..

Eligibility/Qualifications/Requirements
The ideal candidate will need the following experience / skills to be considered:

• 5+ years experience as a Data Associate
• Experience working with Inform
• Experience working in the clinical research industry within a CRO/Pharma/Site
• Experience collaborating with a study team
• Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience.
• The ability to deal effectively with sponsors and internal customers at all levels
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Experience working in a matrix-structured environment is preferred
• Preference will be given to those from previously disadvantaged groups that meets the minimum requirements of the position

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Responsibilities For This Role Are As Follows

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
• Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and assigned data review listings, all different roles used in the study.
• Receives and enters lab normal ranges.
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly and re-queries where appropriate.
• Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
• Runs data cleaning and/or status reports.
• Performs Serious Adverse Event (SAE) reconciliations.

Eligibility/Qualifications/Requirements
The ideal candidate will need the following experience / skills to be considered:

• 2+ years experience as a Data Analyst
• Experience working with Inform
• Experience working in the clinical research industry within a CRO/Pharma/Site
• Experience collaborating with a study team
• Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and
• experience.
• The ability to deal effectively with sponsors and internal customers at all levels
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Experience working in a matrix-structured environment is preferred
• Preference will be given to those from previously disadvantaged groups that meets the minimum requirements of the position