Clinical Research Associate

Description

Hours: 9:00am-5:00 PM–May potentially become a Hybrid role after 3-4 months training, but will be 100 % onsite to start with

Location: Maple Grove, MN 55311

Onsite/Remote: Could possibly be Hybrid role- will be decided once training is completed and manager has had the opportunity to observe the candidate’s work performance

Duration: This is a 6-month contract with potential to extend highly likely

Mnagers updates

• Someone with a Clinical Research Associate central monitoring
• Lot of work is central in managing and supporting clinical studies
• Good understanding of clinical study
• Working with project management team
• Analytical and critical thinking skills, along with related work experience
• Data management/Analysis
• Clinical data management experience
• CRA will be a great match
• 3 years of experience in clinical research
• Data manager will not be a good fit
• Phase 1 2 3
• Pharma or medical device background
• PhD and PharmD will work
• Heavy compliance and documentation skills
• Data management or CRA background
• Bachelor’s degree is really preferred
• Someone with a variety of experience
• Someone with CRA with site monitoring experience will be great
• Medidata or RAVE is the tool

This position for a Clinical Data Manager will oversee 3-5 clinical trials from data management perspective, and together with assigned Coordinator, takes care of all related activities from CRF design, clinical data review and oversight, to trial closure related data activities.

Top Skills Needed:

• Analytical and critical thinking skills along with related work experience,.
• Data management/Analysis (not statistical analysis)with the relative previous past work experience.
• Good Organizational Skills
• Detail Oriented and Ability to multitask.

Experience Needed-

• 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.

Education:

• Education Level-bachelor’s degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent

Licenses and Certifications

• None required; Certified Clinical Data

Summarize the 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.

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 (± 16 years)     Biology, Health Sciences, Mathematics, Computer Science, or equivalent.

Experience Details

• 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.