Senior Clinical Data Associate
Role Overview
The Senior Clinical Data Associate provides data management support and assistance in all 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 perform database development 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 back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May perform data entry for paper-CRF studies, as needed
• May perform 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 all stakeholders
• May 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 third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May 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
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) 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 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
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned.
Full Job Posting
Qualifications:
- Minimum Required:
- 5+ years’ experience
- Bachelors and/or a combination of related experience
- Other Required:
- Proficiency in Microsoft Office: Word, Excel, 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 continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Resolves project related 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
- Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
- 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.
- 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 Precision Medicine Group at [email protected].
- Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
About Precision for Medicine
Global clinical research organization specializing in precision medicine services.
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Precision for Medicine
Associate Scientist, Flow Cytometry
Frederick, USA
Position Summary: The Associate Scientist will be participate in flow cytometry projects through assay development, validation, and execution in a timely manner. Perform assays according to SOPs and support development o
Senior Scientist
Houston, USA
Position Summary: This position will lead protein expression assays on tissues and liquid biopsies (circulating tumor cells, CTCs). Responsibilities include performing assay design and development, validation, and sample
Principal Scientist
Houston, USA
Position Summary: The Principal Scientist will be instrumental in helping Precision achieve its goals of delivering exceptional services to Precision’s diverse, innovative, and global biopharmaceutical clients. Working c
Registered Histotechnician
Houston, USA
Position Summary: The Registered Histotechnician will be responsible for consistent accuracy throughout the processing of tissue sections; while demonstrating efficient work habits and flexibility. Essential functions of
Director, Project Management
, USA
Position Summary: Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordinati
Regulatory and Start Up Specialist
, GBR
Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational
Project Director - Oncology
, USA
Position Summary: The Project Director represents continued advancement upon the project management career track. Responsibilities are defined below and are dependent upon the type and timing of the program to which the
Associate Scientist, Flow Cytometry
Frederick, USA
Senior Scientist
Houston, USA
Principal Scientist
Houston, USA
Registered Histotechnician
Houston, USA
Director, Project Management
, USA
Regulatory and Start Up Specialist
, GBR
Project Director - Oncology
, USA
Principal Biostatistician
London, GBR