Talent.com
Clinical Data Manager
Clinical Data ManagerStrategic Employment Partners • Raleigh, NC
Clinical Data Manager

Clinical Data Manager

Strategic Employment Partners • Raleigh, NC
30+ days ago
Job type
  • Full-time
Job description

We are currently seeking an experienced Clinical Data Manager. In this position, you will lead the cross-functional teams to execute clinical research trials that deem whether new drugs or medical devices/products, are safe and effective.

This position is eligible to be performed as a remote position.

Responsibilities:

  • Act as primary point of contact between organization and CRO for Data Management.
  • Provide support and oversight for the CRO Data Management team on multiple trials.
  • Collaborate with the team on Clinical study design, protocol development, design, and statistical planning/outcomes.
  • Review clinical trial/study protocols and provide commentary if necessary.
  • Provide leadership and support for cross-functional tasks, processes, and training.
  • Provide oversight and manage relationships with vendors
  • Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.
  • Monitor the data cleanup activities performed by CRO.

Requirements:

  • Bachelor’s degree or higher in science, math or related discipline.
  • 3-5 years of CDM experience in pharmaceutical/biotech industry.
  • Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
  • Extensive knowledge of data management processes, including EDC and interactive web response system (IWRS) experience.
  • Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
  • Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials
  • Experience with MediData Rave and decentralized clinical trials highly desired but not necessary.

#zrsep

Create a job alert for this search

Clinical Data Manager • Raleigh, NC

Similar jobs

Regional Sales Manager, Clinical Decisions, Central Region

EBSCO Information ServicesRaleigh, NC, United States
Full-time

EBSCO Information Services (EBSCO) delivers a fully optimized research experience, seamlessly integrated with a powerful discovery platform to support the information needs and maximize the researc...Show more

 • Promoted

VP Data & ML Platforms

DatavantRaleigh, NC, United States
Full-time

Datavant is the data collaboration platform trusted for healthcare.Guided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for or...Show more

 • Promoted

Clinical Management Manager

AccentureRaleigh, NC, United States
Full-time

Job Description Accenture is a global leader in professional services, helping organizations worldwide transform their operations, enhance their growth, and deliver sustainable outcomes across indu...Show more

 • Promoted

Infection Control Clinical Manager

Ironside HRRaleigh, NC, United States
Full-time

Healthcare facility located about an hour from Raleigh, North Carolina is looking for a full-time Infection Control Clinical Manager to join their team.Up to $10, 000 relocation assistance.Infectio...Show more

 • Promoted

Customer Success Manager - Clinical Operations

Veeva SystemsRaleigh, NC, United States
Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.As one of the fastest-growing SaaS companies in hist...Show more

 • Promoted

Home Health Clinical Manager

Humana Inc.Lillington, NC, United States
Full-time

Become a part of our caring community and help us put health first As a Clinical Manager at CenterWell Home Health, reporting to the Branch Director, you will lead and support a team of dedicated c...Show more

 • Promoted

Clinical Project Manager II - Biomarker Study Management (Sponsor-Dedicated | Remote)

Syneos Health, IncMorrisville, NC, United States
Full-time

Description Clinical Project Manager II - Biomarker Study Management (Sponsor-Dedicated | Remote) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate...Show more

 • Promoted

Principal Clinical Data Scientist- Data Management

Syneos Health, Inc.Morrisville, NC, United States
Full-time

Principal Clinical Data Scientist- Data Management.Morrisville, NC, United States.Principal Clinical Data Scientist- Data Management.Syneos Health is a leading fully integrated biopharmaceutical so...Show more

 • Promoted

Executive Director, Clinical Data Science

EisaiRaleigh, NC, United States
Full-time

Executive Director, Clinical Data Science.At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human healt...Show more

 • Promoted

Sr. Technical Project Manager - Data Science

Lexisnexis FranceRaleigh, NC, United States
Full-time

Do you enjoy collaborating cross-functionally to deliver on project success?.Do you want to help us build further data science capabilities?.This position conducts stakeholder negotiations that spa...Show more

 • Promoted

Databricks Data Engineer - Manager - Consulting - Location Open

EYRaleigh, NC, United States
Full-time

At EY, we're all in to shape your future with confidence.We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.Join EY and help ...Show more

 • Promoted

Principal Analytics Analyst - Healthcare Data

SurescriptsRaleigh, NC, United States
Full-time

Surescripts serves the nation through simpler, trusted health intelligence sharing, in order to increase patient safety, lower costs and ensure quality care.We deliver insights at critical points o...Show more

 • Promoted

Clinical Trial Manager (Hyrbid)

ActalentRaleigh, NC, United States
Full-time

Manage clinical trial studies for specific therapeutic areas while providing guidance and oversight to internal and external project team members.Ensure successful management of study operations in...Show more

 • Promoted

Clinical Director

Action Behavior CentersWake Forest, NC, United States
Full-time

APPLICATIONS ARE REVIEWED DAILY.YOU CAN EXPECT A RESPONSE WITHIN 24 HOURS.Our Patients: an intentional focus on small caseloads with a compassionate care approach.Our Culture: Our Core Values are m...Show more

 • Promoted

Manager, Clinical Education

Edwards LifesciencesRaleigh, NC, United States
Full-time

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options.Transcatheter Mitral and Tricuspid Therapies (TMTT) is honored to support clinici...Show more

 • Promoted

Sr. Manager of Data Analytics & Reporting

Public Consulting GroupRaleigh, NC, United States
Temporary

Public Consulting Group LLC (PCG) is a leading public sector solutions implementation and operations improvement firm that partners with health, education, and human services agencies to improve li...Show more

 • Promoted

Data Manager

Wake County Public SchoolsWake Forest, NC, United States
Full-time

Ensures accurate student record keeping by following procedures set forth by Wake County Public School System (WCPSS).Performs data entry processes including analyzing data for students being serve...Show more

 • Promoted

R&I Risk & Quality Data Scientist Senior Manager

PwCRaleigh, NC, United States
Full-time

At PwC, our people in data and analytics engineering focus on leveraging advanced technologies and techniques to design and develop robust data solutions for clients.They play a crucial role in tra...Show more