What are the responsibilities and job description for the Data Manager (Permanent role)- HYBRID - Horsham, PA position at ClinChoice?
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Data Manager on a permanent basis at Horsham, PA. (Hybrid 3 days from our office)
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Summary:
The Data Manager is responsible for managing clinical data throughout the study lifecycle, including the development and maintenance of data management plans, validation plans, and specifications. The position ensures high-quality data delivery through the EDC system, performs user acceptance testing, data reconciliation, and database audits, and provides mentorship to junior team members.
Responsibilities:
- Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms (CRF), and reports).
- Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project, and ensure DMP is followed according to study design and requirements.
- Create and maintain Data Validation Plan and Data Review Plan.
- Create Data Entry Guidelines.
- Create eCRF Completion Guidelines.
- Create Data Transfer Specifications.
- Develop and review electronic Case Report Form (eCRF) and/or paper CRF.
- Develop database (DB) clinical trial data specifications, including eCRF design, edit rules/checks, and query logic and data validations.
- Perform external data reconciliation in collaboration with programmers.
- Develop User Acceptance Testing (UAT) Plan and create and maintain all UAT documents, including but not limited to edit check document, issue logs, and UAT checklists.
- Perform UAT of data entry screens and edit checks.
- Perform site/clinical research associate (CRA) training and create user guides.
- Deliver high quality clinical data within the Electronic Database Capture (EDC) system to ensure successful freeze/lock as appropriate for statistical review, interim review, and or final database lock.
- Perform unfreeze/unlock procedures if required.
- Coordinate the archiving of study databases and related documents.
- Perform database audits for paper studies.
- Perform SAE reconciliation.
- Provide mentorship to junior members. Work with project manager and cross-functional team members to maintain project timeline and overall quality of deliveries.
- Bachelor's degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
- At least 4 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PR1 #Hybrid
