Description:
Job Title: Clinical Data Specialist

Location: Belgium - Leuven area

Schedule: Permanent - Full Time - Office based

TalentSource Life Sciences, a division of CROMSOURCE, is looking for an experienced Clinical Data Specialist to work with one of our top 10 Medical Device clients in the region of Leuven.

Scope of the role:

The objectives of the European Medical and Clinical Division are to organise, manage and conduct clinical trials by respecting all regulatory requirements and Good Clinical practice, to communicate clinical data to wider audience, to manage all medical aspects of company products, and to contribute to the new products and new therapies development.

Responsibilities:

• You'll perform ongoing data cleaning and reviews to assure quality of the data and compliance with SOPs, GCP and ICH Guidelines
• You'll assist in eCRF development, Edit checks and UAT of clinical studies
• You'll create and deliver study-specific site training
• You'll partner with clinical operations personnel to manage the query lifecycle
• You'll be responsible for handling all pre and post production service requests
• You'll assist PDM while developing and maintaining data management processes in compliance with Standard Operating Procedures (SOP)
• You'll ensure accuracy of clinical data through review of CRFs for completeness and consistency
• You'll provide clinical data export or reports to clinical operations team
• You'll partner with external service providers to support department goals
• You'll closely follow the regulations related to conduct of clinical trials in different countries
• You'll assist in updating DM processes to any change in regulation
• You'll assist in SOP preparation and update
• You'll act as representative of the company
• You'll assume all other responsibilities and authorities this function may require regarding new opportunities
• General monthly reporting to Program data manager and divisional manager is also one of your responsibilities

Education and experience:

• You have a Bachelor's or Master's degree in Bio-medical / Pharma / Life science / Informatica
• You have industrial experience of about 3-5 years in data management for clinical trial
• You have good knowledge of MS Excel, Access and PowerPoint
• You're experienced with EDC systems
• You're a team player, who's able to work in an international environment
• You are fluent in English
• You have the ability to motivate in a dynamic environment

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001970

If you would like to discuss the role before applying through the website, please contact Rocio.EgeaMota@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Clinical Data Management, Clinical Trial, Regulatory, GCP

Skills: Data Manager Location: Belgium Share:

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