Clinical Data Manager

Main Purpose of the Role: The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans. As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address  Diresh.Krishnan@generistek.com can be reached on # (630) 576-9065.
 
We have Contract role Clinical Data Manager for client at Maple Grove, MN. Please let me know if you or any of your friends would be interested in this position.
 
Position Details:
Clinical Data Manager- Maple Grove, MN
Location                       : Maple Grove, MN – 55311
Project Duration      : 6 Months of contract (Potential to Extend)
Shift Timing               : 8:00 AM to 4:00 PM (Mon to Fri)
Pay Rate                      : $44.00 per hour on W2
 
Main Purpose of the Role:

• The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.
• As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

 
Responsibilities:

• Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
• Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities, as described in Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.

 
Top Skills Needed:

• Analytical and critical thinking skills along with related prior data management experience.
• Great communication skills with a focus on collaboration.
• Confident in leading discussions and managing complex regulated studies.
• Experience in effectively influencing a team decision to the desired outcome.

 
Education:

• Bachelors’ degree in Biology, Health Sciences, Mathematics, Computer Science, or equivalent.

 
Experience:

• 3 years in clinical operations or healthcare related field.
• Education and work experience in project management, life sciences and/or technical field.
• Knowledge of data collection best practices for clinical trials.
• Knowledge of global clinical operations.
• Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.
• Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.
• Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.
• Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.
• Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.
• Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.

 
Licenses & Certifications:

• None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.

 
 
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address  Diresh.Krishnan@generistek.com can be reached on # (630) 576-9065.
 
About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.