Contract Clinical Data Manager - 1 FTE - 3 months

at  Ergomed

Milano, Lombardia, Italy -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate16 Sep, 2024Not Specified18 Jun, 2024N/AGood communication skillsNoNo
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Description:

Company Description
Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description

Participating in various data management activities from initiation of protocol through database lock data cleaning activities

  • Have ability to support multiple moderate complexity / complex trials with minimal supervision
  • May enter Data from trial documents into data entry system
  • May perform Medical Coding,
  • Manage the entry, review, and tracking of Local/Central Lab reference ranges
  • May provide input for data management documentation and processes
  • Perform validation of EDC Systems and associated DM reports or listings
  • Perform validation of EDC and SAS edit checks
  • Manage and Create EDC user accounts
  • Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project

Data Manager (PDM)

  • Performs specified activities that contribute to the creation of database specifications, database

build and user acceptance testing during database and edit check development.

  • Attend internal/external teleconferences as needed
  • May create and review study metric reports for internal/external project teams
  • Notify management of roadblocks for getting processes done in a timely manner and offer

possible solutions

  • Provide the PDM with status updates on tasks that are assigned
  • Escalates significant issues promptly to the study team

Qualifications
Bachelor’s Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline
In lieu of a bachelor’s degree, 2-3 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Milano, Lombardia, Italy