Data Manager Consultant (Remote)

Posted Yesterday
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Hiring Remotely in European Union
Remote
Mid level
Pharmaceutical
The Role
Leads clinical trial data management activities from database setup through close-out. Responsibilities include reviewing protocols and CRFs, creating eCRF specifications and data management plans, developing edit checks and query logic, conducting user acceptance testing, training clinical teams, reviewing and reconciling data, managing database locks, coordinating archiving, and overseeing data transfers and SAE reconciliation while meeting quality and timeline requirements.
Summary Generated by Built In

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Data Manager on a contractor basis. 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and close-out. The Data manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key responsibilities may include, but are not limited to:

  • Lead Data management activities and ensure study deliverables meet timelines and quality standards.
  • Review of Clinical research documents (e.g. protocols, Case Report Forms).
  • Create and review electronic Case Report Form (eCRF) specifications.
  • Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
    Develop edit rules/checks, query logic and query messages.
  • Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
  • Create and provide training to the clinical team and sites.
  • Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
  • Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
  • Coordinate the archiving of study databases and related documents
  • Create Data Transfer Specifications and perform external vendor reconciliation.
  • Perform SAE reconciliation.
  • Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.

Qualification

  • Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
  • Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
  • Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
  • Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
  • Perform duties in compliance with SOPs, GCP and ICH guidelines.
  • Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
  • Ability to lead a study or data management team independently.
  • Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
  • Excellent verbal and written communication skills.
  • Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.


#LI-DNP

Skills Required

  • Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, or a related field, or a nursing degree
  • At least 3 years of data management or related work experience in the pharmaceutical industry
  • Working knowledge of clinical research, clinical trial processes, regulatory requirements, and related terminology
  • Strong knowledge and experience with several electronic data capture systems, including Medidata Rave, Oracle InForm, OpenClinica, and Medrio
  • Ability to perform duties in compliance with SOPs, GCP, and ICH guidelines
  • Ability to prioritize and adapt quickly in a fast-paced, changing industry
  • Ability to independently lead a study or data management team
  • Ability to drive quality and efficiency to meet timelines and milestones
  • Excellent verbal and written communication skills
  • Proficiency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint

ClinChoice Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.

  • Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
  • Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
  • Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.

ClinChoice Insights

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The Company
HQ: Fort Washington, PA
5,000 Employees
Year Founded: 1995

What We Do

ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.

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