Senior Data Manager

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Data Manager Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Summay

The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the studies from design through final analysis and study closeout. The individual is accountable for ensuring study launch conduct and closeout are performed according to client quality standards Good Clinical Practices (GCPs) and International Conference on Harmoization (ICH) guidelines to to be compliant with all federal and local regulations.

Main Accountabilities:

• Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.

• Provide expertise and oversight of all clinical database activities from design/start-up to closeout.

• Reviews protocols for appropriate data capture including electronic (eCRF) design

• Support CRF design review and validation of clinical database.

• Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.

• Conducts oversight of data management vendors via ongoing review of quality and performance metrics. May also conduct ongoing TMF review to ensure all data management-related documents are complete and filed.

• Generates resolves and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.

• Facilitates and participates in datacleaning activities.

• Generates and/or reviews/approves study documents (Data Management Plan CRF Completion Guidelines DB build specifications Edit Check Specifications Data Transfer Specifications SAE and/or External Data Reconciliation Plans Coding Guidelines Vendor Management Plans etc.)

• Review CRF metrics reports against project data deliverables

• Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.

• Proactively identifies potential data management issues/risks and communicates it within the study team for further action.

• Participate in process improvement activities resulting in increases in productivity quality and/or cost effectiveness

Preferred Qualifications:

• Minimum BA/BS in scientific or health-related field.

• Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical biotechnology industry or in a CRO.

• Either oncology or auto-immune experience required.

• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g. ICH/FDA guidance CDISC standards GCDMP 21 CFR 11 MedDRA WHO Drug Dictionaries etc.) and their application to DM practice

• Proficient with Medidata RAVE.

• Experience with working on Medidata Suite products (Safety Gateway ePRO RTSM) preferred

• Familiarity with various data visualization analytics and reporting tools is a plus

• Excellent communication skills (verbal and writing).

• Ability to multi-task and take on new responsibilities as needed in a fast-paced small company setting.

• Experienced using Microsoft Office applications (Word Excel PowerPoint etc.)

• Strong organizational skills and ability to prioritize tasks.

• Proven ability to work independently and in a team setting.

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 4000 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-TT1 #LI-Remote #Senior #FTE