DM Quality Control Specialist

DM Quality Control Specialist - propharma group

Datum der Veröffentlichung: Jan 24, 2023

Auftragsdetails

Ort:

Overland Park, Kansas, United States of America
Gesellschaft:

propharma group
Typ:

Full Time/Permanent
Shift:

First Shift (Day)
Karrierelevel:

Experienced Professional
Positionen:

4
Erfahrung:

3 Year
Geschlecht:

Keine Präferenz
Grad:

Bachelors
Vorher bewerben:

Nov 30, 2023

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Job Summary

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Detailed Description

Essential Functions:

Ability to take ownership for the quality control of the Data Management projects/programs
Ensure that all data management activities are conducted in line with regulatory guidelines, global Standard Operating Procedures (SOPs), and client expectations.
Works with the Director, Data Management Operations and Associate Directors, Data Management to identify root cause of any gaps in processes or documentation, strategizes on mitigation plan and assists in the execution of that mitigation plan.
Ensure all necessary documentation is created and filed in the eTMF correctly.
Perform regular reviews of the DM eTMF to ensure eTMF compliance

Assist in other operational duties as directed by Data Management leadership

Necessary Skills and Abilities:

Strong project management skills and technical aptitude.
Experience in Contract Research Organization (CRO) or pharmaceutical/biotechnology company preferred
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
Ability to handle multiple tasks to meet deadlines in a high stress environment.
Basic computer skills in Word, Excel, and email. Industry standard system experience preferred.

Expertise with EDC systems, such as Medidata Rave, InForm, IBM Clinical, Veeva EDC or Medrio

Experience Requirements:

Minimum 5 years in Clinical Data Management
Minimum 1 year acting as a Lead Data Manager on one or multiple projects (start start-up through database lock)

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Fähigkeiten benötigt

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Company Overview

propharma group

Berlin, Berlin, Germany

0 Aktuelle Stellenangebote

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More

Auftragsdetails