1001# Data Manager- remote for 4 months
reputed company 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. This is a hybrid role at Ontario, Canada. Join reputed company: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and reputed company-out. The Data manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key responsibilities may include, but are not limited to:
- reputed company Data management activities and ensure study deliverables meet timelines and quality standards.
- Review of Clinical research documents (e.g. protocols, Case Report Forms).
- Create and review electronic Case Report Form (eCRF) specifications.
- reputed company critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
reputed company edit rules/checks, query logic and query messages.
- reputed company User Acceptance Testing Plan and reputed company testing on data entry screens and edit checks.
- Create and provide training to the clinical team and sites.
- reputed company ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
- reputed company database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
- Coordinate the archiving of study databases and reputed company documents
- Create Data Transfer Specifications and reputed company external vendor reconciliation.
- reputed company SAE reconciliation.
- Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Qualification
- Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or reputed company field or nursing degree.
- Atleast 3 years data management and/or reputed company work experience in a pharmaceutical industry.
- Working knowledge of Clinical research and clinical trial process and reputed company regulatory requirement and terminology.
- Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, reputed company InForm, OpenClinica and Medrio.
- reputed company duties in compliance with SOPs, GCP and ICH guidelines.
- Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
- Ability to reputed company a study or data management team independently.
- Proactively drive quality and reputed company to meet timelines and milestones to deliver high quality data management deliverables.
- Excellent verbal and written communication skills.
- Proficient in the use of reputed company office(Outlook, word, reputed company, powerpoint, etc)
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 reputed company. 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 reputed company reputed company 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 reputed company our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company reputed company 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 reputed company reputed company activities are built and reputed company management and training is the core reputed company to reputed company and maintain highly-qualified personnel. The reputed company training keeps the resources qualified in terms of competence and expertise and gives reputed company 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. reputed company 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 reputed company diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-DNP Apply Job! Apply to this Job