Senior Data Manager Consultant

ClinChoice; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ClinChoice is seeking a Senior Data Manager Consultant to lead data management activities for clinical trials, including database setup, study conduct, and close-out. You will collaborate with a cross-functional team to deliver high-quality DM deliverables and meet timelines.

Responsibilities include creating DM documents, developing eCRF specifications, testing data entry screens, and training clinical teams and sites, while maintaining strong client relationships and adherence to GCP/ICH

Qualifications

• Minimum 3 years data management experience in pharmaceutical industry.
• Experience reviewing clinical trial documents (protocols, CRFs).
• Proficiency with eCRF design and data management deliverables.
• Familiarity with data quality checks, DB locks, and data reconciliation.

Responsibilities

• Lead data management activities to meet timelines and quality
• Review clinical study documents (protocols, CRFs)
• Create and review eCRF specifications
• Develop DM documents: DM Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines, Data Review Plan
• Develop edit rules, query logic and messages
• Develop UAT plan and test data entry screens
• Provide training to clinical team and sites
• Perform data reviews and patient tracking for data cleanup
• Coordinate database lock/unlock and final database lock
• Coordinate archival of study databases and related docs
• Create Data Transfer Specifications and perform external vendor reconciliation
• Maintain client satisfaction with high-quality data management services

Skills

Data management

eCRF development

DM plan development

Regulatory knowledge (GCP/ICH)

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field

Tools

Medidata Rave

Oracle InForm

OpenClinica

Medrio

Job description

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 an 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.

The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and close-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:

• Lead 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.
• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
  Develop edit rules/checks, query logic and query messages.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
• Create and provide training to the clinical team and sites.
• Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
• Perform 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 related documents
• Create Data Transfer Specifications and perform external vendor 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 related field or nursing degree.
• Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
• Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
• Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
• Perform 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 lead a study or data management team independently.
• Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
• Excellent verbal and written communication skills.
• Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)

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.