Clinical Data Manager Job at Planet Group, Maple Grove, MN

TkJ2ZHg1QzRBQU9kWXE0eFdvVXNkRnZUUkE9PQ==
  • Planet Group
  • Maple Grove, MN

Job Description

MAIN PURPOSE OF 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.

MAIN 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.

QUALIFICATIONS
Bachelors Degree Biology, Health Sciences, Mathematics, Computer Science, or equivalent.    
Minimum 3 years: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 and Certifications
None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.

Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians. This position is Non-Exempt-located onsite in Maple Grove

Pay ranges between $38-43.30/hr based on experience 

Job Tags

Contract work, Work experience placement,

Similar Jobs

Houston Methodist

Application Analyst - EPIC Radiant (Hybrid) Job at Houston Methodist

 ...LICENSES AND CERTIFICATIONS - REQUIRED ~ Certification within six months of hire if appropriate to assigned application. (i. e. Epic) Epic Certification must be maintained within 6 months KNOWLEDGE, SKILLS, AND ABILITIES ~ Demonstrates the skills and competencies... 

Marquis Home Care

HOME HEALTH AIDES AND PERSONAL CARE AIDES NEEDED Job at Marquis Home Care

 ...Home Health Aide/Personal Care Aide Schedule: Full Time & Part Time Hours available -Westchester County Home Health Aide or Personal Care Aide Responsibilities: Assists with personal care activities Assists with household tasks Meets safety needs of clients... 

DES Employment Group

Electrician - Apprentice Job at DES Employment Group

 ...Commercial Electrical Apprentice for Commercial work in St. Louis, MO $17-$30 working trial basis then renegotiate Qualifications...  ...experience as a Commercial, Residential, and Industrial apprentice electrician, with a strong portfolio of assistance in commercial projects... 

Capital Ford of Charlotte

Automotive Parts Counterperson - Level 3 Job at Capital Ford of Charlotte

 ...Parts Sales & Support - Help customers and technicians identify and order the correct parts at the counter, over the phone, or in the shop.* Learn Our Systems - Receive training on our dealership-specific processes, including parts software, order procedures, and... 

Sutter Health

Respiratory Education Specialist Job at Sutter Health

We are so glad you are interested in joining Sutter Health!**Organization:**MPHS-Mills-Peninsula Medical Center**Position Overview:**Plans, coordinates, participates in the education, competency, quality assessment and improvement programs for pulmonary services of...