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Clinical Data Manager (Freelance)

Employer
NonStop Consulting
Location
Brussels
Salary
Negotiable
Closing date
Feb 24, 2021

View more

Sector
Pharmaceutical, Data Management/Statistics
Contract Type
Contract/Freelance
Hours
Full Time
Organization Type
Corporate

Job Details

One of my clients, an established biotechnology company that focuses on taking a pioneers role in discovering and developing life-improving medicines is currently looking for a clinical data manager to help out with the big increase of clinical trials that will be starting soon. This concerns a freelance or temporary project at a company with an entrepreneurial and make-it-happen mentality, yet with a friendly and family atmosphere. As clinical data manager you will be in a CRO over-sight role mainly.

Responsibilities:

The Data Management Leader is a functional expert in the field of Clinical Research Data Management (DM), and as such supports the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials. Main responsibilities are:

  • Participate in CST meetings as DM representative, and closely interact with Biostatistics, Medical, Clinical Operations and other functional representatives
  • Provide data management expertise during protocol development, including for any amendments
  • Coordinate DM Contract Research Organization (CRO) Request for Proposal (RfP) selection process, create necessary Purchase Order (PO) Requests and follow up on related Goods Receipt (GR)
  • Act as first point of contact for DM CRO counterparts and ensure clinical study data management deliverables within agreed budget and timelines, and with high quality (complying with company processes, ICH-GCP and applicable regulations and guidelines)
  • Organize relevant data management oversight meetings and ensure minutes are documented
  • Create and maintain Data Management Oversight Plan and ensure proper execution of necessary quality control steps
  • When InForm is used, ensure necessary steps are taken to get DM CRO started, and provide further support where needed
  • Ensure proper and timely filing of DM-specific documents and files in Trial Master File or other secured dedicated environment
  • Actively participate in DM and Biometrics team meetings
  • Adhere to relevant policies and procedures and ensure timely completion of relevant training
  • Interact with Quality & Compliance to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
  • Lead or contribute to Process Improvement initiatives as required

Requirements:

  • BSc or preferably MSc in (biomedical) sciences, including a statistical part of curriculum, preferably a MSc in statistics
  • At least 3 years experience in an CDM role with CRO over-sight.
  • Expert knowledge in SDTM, ADaM and CDISC standards
  • Preferably proficient in related SAS programming procedures and macro's

Benefits:

  • Over-sight role
  • Can be worked mainly remotely
  • Contract of 6 or 12 months with possibility to extension
  • Great dynamic and pioneering environment to gain more expertise

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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