Clinical Data AssociateSenior Clinical Data Associate

Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision you will ensure adherence to Standard Operating Procedures (SOPs) regulatory guidelines and studyspecific plans. This role encompasses a range of responsibilities including data cleaning and reconciliations database testing quality control and collaboration within a dynamic team environment.

Position Summary:

The Clinical Data Associate/Senior Clinical Data Associate provides data management support and assistance in all aspects ofthe clinical trial data management process from study start up to post database lock for assigned projectsunder direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatorydirectives: study specific plans and guidelines will be followed. This position may perform databasedevelopment and testing as well as additional data management activities.

Essential functions of the job include but are not limited to:

• Support the Lead DM as a backup and/or team member ensuring continuity responsiveness
• and that tasks are performed in a timely manner
• Perform data entry for paperCRF studies as needed
• Perform quality control of data entry.
• Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects as needed.
• Assist in developing CRF specifications from the clinical study protocol and coordinate the
• review/feedback from all stakeholders
• Assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation. May
• oversee overall quality of the clinical database.
• Assist in specifying requirements for all edit check types e.g. electronic manual data review edit checks etc.
• Responsible for creating revising appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF EDC and other project related items
• as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation.
• Assist with liaising with thirdparty vendors such as external data and EDC vendors in a project manager capacity in support of timelines and datarelated deliverables
• Assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems issues obstacles and barriers for studies based on metrics data audit reports and input from project team members and other stakeholders.
• Assist in reviewing and providing feedback on protocols Statistical Analysis Plans (SAP) and
• Clinical Study Reports (CSRs) if required by the project
• Assist in participating in the development and maintenance of Standard Operating
• Procedures (SOPs) and corresponding process documentation related to data management and
• database management activities
• Trains and ensures that all data management project team members have been sufficiently trained.
• Communicate with study sponsors vendors and project teams as needed regarding data database or other relevant project issues.
• Present software demonstrations/trainings department/company training sessions present at project meetings
• Perform other duties as assigned.

Qualifications

Minimum Required:

• 4 years experience within Data Management
• Bachelors within scientific/science background and combination of related experience

Other Required:

• Proficiency in Microsoft Office: Word Excel PowerPoint Outlook.
• Able to handle a variety of data management task and oversight.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Basic knowledge of drug device and/or biologic development and effective data management
• practices

Preferred:

• Experience in a clinical scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH SDTM ADaM etc.
• Oncology and/or Orphan Drug therapeutic experience

Skills:

• Demonstrates strong knowledge of ICHGCP relevant Precision Oncology SOPs and regulatoryguidance as well as the ability to implement and drive outcomes

Competencies:

• Motivates project team members to meet timelines and project goals
• Focuses on continuous improvement including the ability to make proactive assessments on howto make processes more efficient and people more effective
• Resolves project related problems and prioritizes workload to meet deadlines with minimalsupport
• Exhibits a high degree of selfmotivation and can work and plan independently as well as in ateam environment
• Demonstrates an acceptable degree of professionalism as evidenced by punctuality ability todeliver on commitments an understanding of the service culture and positive interactions withcustomers and teammates including good interpersonal skills

Precision for Medicine is a precision medicine CRO. Precisions uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs industryleading operational and medical experts advanced biomarker and data analytics solutions and an unequivocal real passion for rare diseases and oncology in addition to working across other therapeutic areas.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law. 2020 Precision Medicine Group LLC

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