Clinical Data Manager - job 1 of 2

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Company Description

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

To support our expansion efforts, we are looking to add to our team a person that is experienced in clinical abstraction and large project operations
The role will require wearing many hats and Tempus is looking for an individual that is able to coordinate, grow and maintain the abstraction effort, ensuring abstraction processes are run efficiently and data is captured at the highest quality level while meeting project expectations
As a Clinical Data Project Manager (CPM), you will be responsible for managing the data abstraction team that supports the clinical data abstraction for the Studies pipeline
Abstractors review clinical records and structure key data elements into an electronic data capture (EDC) system in alignment with Tempus abstraction rules
The CPM will be responsible for clearly articulating project updates to key stakeholders and collaborate with the Studies team to support transparency and process improvement
You will work closely with the Clinical Studies Manager
Answer escalated cases-specific inquiries that requires clinical expertise/knowledge and ability to apply said knowledge to proprietary data abstraction guidelines
Assist and oversee training of new abstractors and quality analysts on established and/or new cancer subtypes in conjunction with Studies Data Management team
Maintain abstraction quality by developing, interpreting and tracking standards for accuracy of data and implementing corrective action plans as necessary
Ensure data capture is in alignment with Tempus abstraction standards and rules
Act as a conduit between the abstractors and the Studies team, surfacing RWD related issues as they relate to the active cohorts and available information
Stay on top of all due dates, and keep active communication to ensure that projects are kept on time or that timelines are revised to appropriately reflect necessary time to completion
Collaborate with the project-specific study team to review specific data elements post case submission to ensure accuracy and completeness

Requirements:

This is an ideal position for someone with both a scientific / clinical and a project management background who is interested in working at the crossroads of healthcare technology and data analysis to solve some of today’s most challenging medical questions
2+ years project management experience
Experience in data entry and/or study builds in Medrio or other EDC systems is necessary
High comfort level working across multiple therapeutic areas and/or cancer subtypes
Knowledge of medical and genomic terminology, medical abbreviations and pharmacy terms and familiarity with medical documentation/EMR document structure
Experience in a fast-paced environment
Excellent interpersonal, written and verbal communication skills
Strong leadership skills, ability and willingness to work in an agile and expanding team environment
Willingness to be flexible and adapt quickly.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Average salary estimate

$70000 / YEARLY (est.)

min

max

$60000K

$80000K

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What You Should Know About Clinical Data Manager, Katalyst Healthcares & Life Sciences

Are you ready to take your career to the next level? Katalyst Healthcares & Life Sciences is seeking a Clinical Data Manager to join our passionate team! Located in the heart of Chicago, IL, this role is perfect for someone who thrives in a dynamic environment and is eager to support our efforts in the clinical trials sector for drugs, biologics, and medical devices. As a Clinical Data Manager, you'll be at the forefront of project operations, managing data abstraction teams, and ensuring that our clinical data meets the highest standards. Your responsibilities will include overseeing the abstraction process, collaborating closely with the Clinical Studies Manager, and articulating project updates to stakeholders. If you have a background in project management along with a passion for data analysis and a strong understanding of clinical terminology, this position could be your ideal fit. You'll lead a team to capture critical data accurately and will have a hand in training new abstractors and quality analysts. Your leadership will maintain high-quality standards while navigating fast-paced projects. If you have 2+ years of project management experience, excellent communication skills, and a keen interest in healthcare technology, we'd love to hear from you! Join us in addressing some of the most pressing medical challenges today with your expertise and enthusiasm.

Frequently Asked Questions (FAQs) for Clinical Data Manager Role at Katalyst Healthcares & Life Sciences

What responsibilities do Clinical Data Managers at Katalyst Healthcares & Life Sciences have?

Clinical Data Managers at Katalyst Healthcares & Life Sciences are responsible for overseeing the data abstraction process for clinical trials. This role includes managing a team of abstractors, ensuring data is captured accurately, articulating project updates to stakeholders, and maintaining high-quality standards throughout the abstraction process.