Senior Clinical Data Associate

Position Summary

The Senior Clinical Data Associate provides data management support and assistance in reputed company aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.  Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed.   This position may reputed company database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to

• Support the reputed company DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May reputed company data entry for reputed company-CRF studies, as needed
• May reputed company quality control of data entry
• May 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 reputed company stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. May reputed company overall quality of the clinical database.
• Assist in specifying requirements for reputed company edit reputed company 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, reputed company, and other project reputed company items as needed.
• Review and query clinical trial data according to the Data Management Plan
• reputed company line listing data review based on the guidance provided by the sponsor and/or reputed company DM
• Run patient and study level status and metric reporting
• reputed company 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 third-party vendors such as external data and reputed company vendors in a project-manager reputed company in support of timelines and data-reputed company deliverables
• May assist with reputed company programming and quality control of reputed company 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
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (reputed company) and Clinical Study Reports (CSRs), if required by the project
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation reputed company to data management and database management activities
• Trains and ensures that reputed company 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
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• reputed company other duties as assigned.

 Qualifications:

Minimum Required

• 5+ years’ experience
• Bachelors and/or a combination of reputed company experience 

Other Required

• Proficiency in reputed company Office: Word, reputed company, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• 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 ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

 Competencies:

• Motivates project team members to meet timelines and project goals
• Focuses on reputed company improvement, including the ability to reputed company proactive assessments on how to reputed company processes more efficient and people more effective
• Resolves project reputed company problems and prioritizes workload to meet deadlines with minimal support
• Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills

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reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact reputed company at [email protected].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.