Talent.com
Clinical Data Manager
Clinical Data ManagerKatalyst HealthCares & Life Sciences • Boulder, CO
Clinical Data Manager

Clinical Data Manager

Katalyst HealthCares & Life Sciences • Boulder, CO
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Responsibilities:
  • Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
  • Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities
  • Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
  • Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
  • Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
  • Provide program/study level oversight and expertise for CDM activities for multiple studies
  • Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
  • Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
  • Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
  • Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
  • Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
  • Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
  • Assist with routine quality audits as applicable

Requirements:
  • Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
  • years' industry experience in CDM in all study phases and activities from startup to archival with at least years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
  • Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
  • Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
  • Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
  • Working knowledge of the MedDRA and WHODrug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger
  • Experience in implementing, validating, and administrating other clinical systems for data collection (, eSource, IVRS, IWRS, core lab web-based portals)
  • Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks
  • Excellent verbal and written communication skills

[job_alerts.create_a_job]

Clinical Data Manager • Boulder, CO

[internal_linking.similar_jobs]
Clinical Research Manager

Clinical Research Manager

Element Materials Technology • Boulder, CO, United States
[job_card.full_time]
Element has a current opening for a.Louisville, CO for a full time position.The main responsibility of the.Phases 0-2), ensuring compliance with protocols and regulatory standards and directly mana...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Remote Body Imaging | Denver, CO | 7 On/14 Off | 75k Sign-On + Partnership

Remote Body Imaging | Denver, CO | 7 On/14 Off | 75k Sign-On + Partnership

Jackson Physician Search • Golden, US
[filters.remote]
[job_card.full_time]
An established physican led radiology group that has been around for over 75 years is seeking a board certified or board eligible body imaging radiology to join their team.Practice ANYWHERE in the ...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Healthcare Strategy & Transformation Senior Consultant

Healthcare Strategy & Transformation Senior Consultant

Guidehouse Careers • Boulder, CO, United States
[job_card.full_time]
Job Family Strategy & Transformation Consulting Travel Required Up to 10% Clearance Required Ability to Obtain Public Trust What You Will Do Senior Consultants help our healthcare clients transform...[show_more]
[last_updated.last_updated_1_day] • [promoted]
Quality Assurance Manager

Quality Assurance Manager

The Good Crisp Company • Boulder, CO, United States
[job_card.full_time]
The Good Crisp Company is a rapidly growing snack brand, offering great-tasting, guilt-free snacks designed for healthier lifestyles.Our products are Certified Gluten-Free, NON-GMO Project Verified...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Sr. Project Manager, EU CRA

Sr. Project Manager, EU CRA

Particle Measuring Systems • Niwot, CO, United States
[job_card.full_time]
Project Manager, EU Cyber Resilience Act (CRA) Compliance.Project Manager, EU Cyber Resilience Act (CRA) Compliance who will contribute to the success of the Regulatory Affairs / Compliance / IT Se...[show_more]
[last_updated.last_updated_30] • [promoted]
Clinical Research Coordinator

Clinical Research Coordinator

US Oncology Network-wide Career Opportunities • Boulder, CO, United States
[job_card.full_time]
Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Coordinator I in Boulder.We realize...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
BIOPHARMACEUTICAL - C&Q Manager

BIOPHARMACEUTICAL - C&Q Manager

MMR Consulting • Boulder, CO, United States
[job_card.full_time]
Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries.Its servic...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Assistant Manager

Assistant Manager

Panda Restaurant Group • Golden, CO, United States
[job_card.full_time]
Panda Express is searching for experienced leaders to join our store management team.Panda is 100% committed to the professional and personal development of our family of associates.That's why we o...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Hematology-Oncologist Needed in Golden, Colorado

Hematology-Oncologist Needed in Golden, Colorado

CHG Healthcare • Golden, CO, US
[job_card.full_time]
Golden is a city and former gold rush town at the foothills of the Rocky Mountains, in Colorado.It has world class outdoor recreation.Clear Creek Trail is a network of paths running along a waterwa...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Certified Occupational Therapist Assistant (COTA)

Certified Occupational Therapist Assistant (COTA)

WellTech Partners • Boulder, CO, United States
[job_card.full_time] +1
About the job Certified Occupational Therapist Assistant (COTA).Pediatric Home Health Certified Occupational Therapy Assistant (COTA).Full-Time (19+ visits/week) | Part-Time (10+ visits/week) | PRN...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Sr. Wealth Manager, Growing RIA: High Earning Potential

Sr. Wealth Manager, Growing RIA: High Earning Potential

New Day Executive Search • Boulder, CO, United States
[job_card.full_time]
A nationally recognized wealth management firm ($40B AUM) is looking for an experienced Senior Wealth Manager to join its expanding Private Wealth practice.This is a high-impact role for a seasoned...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Location Manager

Location Manager

gpac • Boulder, CO, United States
[job_card.full_time]
We are currently working on behalf of a stable Ag retail company that is actively searching for a Location Manager who can provide oversight of the day-to-day operations of their Agronomy facilitie...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Associate Clinical Data Manager

Associate Clinical Data Manager

Katalyst Healthcares and Life Sciences • Boulder, CO, United States
[job_card.full_time]
Electronic Data Capture (EDC) systems and Case Report Forms (CRFs).Support database setup activities including edit check specifications and user acceptance testing (UAT).Review incoming clinical d...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Urgent Care Physician Assistant or Nurse Practitioner | Golden, CO

Urgent Care Physician Assistant or Nurse Practitioner | Golden, CO

NextCare Urgent Care • Golden, CO, US
[job_card.full_time]
NextCare Urgent Care is seeking an energetic, patient-centered.Physician Assistant or Nurse Practitioner.This is a full-scope urgent care and occupational health role in a fast-paced setting that o...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Registered Nurse Labor and Delivery

Registered Nurse Labor and Delivery

Intermountain Health • Golden, CO, United States
[job_card.full_time]
The Registered Nurse (RN) is a professional caregiver who assumes responsibility and accountability for assessing, planning, implementing, and evaluating the care of patients.The staff RN utilizes ...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Paid Focus Group Panel - Remote Work From Home Online (Data Entry Clerks Welcome)

Paid Focus Group Panel - Remote Work From Home Online (Data Entry Clerks Welcome)

Apex Focus Group LLC • Golden, Colorado, United States
[filters.remote]
[job_card.full_time]
We're currently looking for individuals across the country to take part in online paid research, including remote focus groups, product trials, and consumer studies.Earn up to $750 a week in your f...[show_more]
[last_updated.last_updated_30] • [promoted]
Project Manager

Project Manager

My3Tech Inc • Golden, CO, United States
[job_card.full_time]
Location: 3500 Illinois Street, Suite 2500 Golden, Colorado 80401 (Hybrid).Client: State of CO( Jefferson County).Candidate must live in Colorado.Position is open only to Colorado residents.Intervi...[show_more]
[last_updated.last_updated_variable_days] • [promoted]
Staff - CT Technologist - UCHealth

Staff - CT Technologist - UCHealth

UCHealth • Jamestown, Colorado, US
[job_card.full_time]
UCHealth (Colorado) is seeking a CT Technologist for a job in Louisville, Colorado.Job Description & Requirements Specialty: CT Technologist Discipline: Allied Health Professional Duration: Ongoing...[show_more]
[last_updated.last_updated_variable_days] • [promoted]