Clinical Systems Coordinator – Belgium

The Clinical Systems Coordinator is responsible for the overall coordination and management of the set-up, implementation, design and maintenance, development and security of various clinical information systems including but not limited to Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and electronic Data Capture (EDC) systems, Electronic Health Record (EHR) among others.

• In collaboration with the management, determines overall strategy in building and shaping the clinical systems and IT structure within the company.
• Develops, maintains, and oversees applicable SOPs and templates to ensure that routine clinical systems operations are performed in adherence with ICH/GCP/regulatory guidelines and established best practices in collaboration with the Quality manager.
• Advises on policies and latest trends on clinical systems and information security across the organization.
• Manages projects to ensure effective integration of clinical systems as appropriate.
• Leads in searching and selection of suitable system vendors.
• Guides the team in the development and design of a compliant GxP in-house clinical system applications and tools and ensures validation of these tools.
• Leads process improvement initiatives to streamline and standardize system processes.
• Leads user training (internal and external) and train-the-trainer training sessions, establishing, and maintaining user reference materials for all user types.
• Delegates task appropriately and coaches the team as needed.
• Liaise with different system vendors for system updates and technical inquiries.
• May participate in activities related to building study databases and applies advanced knowledge in the programming of complex CRF design, database building, edit checks, intermediate to complicated reports, custom programming, system interfaces and all system feature configurations.
• May provide guidance /advice to customers on the selection, implementation, and management of clinical systems in accordance with the SOW.
• May act as an administrator in the applicable clinical systems.

Skills and Qualifications:

• Bachelor or master’s in computer science, software or application development or other IT related courses.
• Proven experience in software and application development.
• Working knowledge of clinical trial operations and/or clinical data management
• Strong background of 21 CFR part 11 and GAMP5 is desirable
• With good communication and interpersonal skills.
• Familiarity with project management
• Agile and with Can-Do attitude.
• Affinity with lean principles
• Passionate about technology and always go the extra mile to get the most suitable technological solution
• Strong leadership and coaching skills

Your Education:

Bachelor’s degree, in health care or other scientific discipline or educational equivalent or equivalent combination of education, training and experience.

If you are interested, please send us your CV and motivation and get in touch with us at hr@clinitude.com

Clinical Data Associate (CDA) – Cebu

A CDA is accountable for proper capturing, recording, documenting of clinical research data for clinical study and for validation.  A CDA must make sure that the clinical studies and/or clinical study protocols are completed consistently, as well as making sure they are verifiable clinical data that must exist to back-up the research. Read more “Clinical Data Associate (CDA) – Cebu” →

Clinical Research Associate Liaison (CRA LIAISON) – Cebu

Have you always been interested in how new drugs/devices are being developed, tested and registered? Clinitude, a long time partner of Gemango is looking to welcome you to become a part of the Cebu CRA team! Read more “Clinical Research Associate Liaison (CRA LIAISON) – Cebu” →

Clinical Research Associate – Belgium

We are looking for Clinical Research Associate(s) to join our team in Belgium.    Supporting the clinical research by selecting the right sites to participate in clinical study, performing initiation visits and monitoring visits to ensure good quality of data and managing the site study team are the key ingredients for this role.  Are you interested to contribute to science, we just ask you to send us your CV and start your CRA carreer.

Your Responsibilities:

• Perform site selection if applicable, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of the study site.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable can be involved in the review of monitoring documents (e.g. monitoring plan, review of monitoring visit reports….).
• To implement a quality management plan
• To ensure timely resolutions for compliance issues

What do we ask from you?

• basic knowledge of clinical research
• strong written and verbal communication skills
• strong organizational and problem-solving skills
• effective time management
• ability to establish and maintain effective working relationships with colleagues, managers and clients
• degree in health care or scientific discipline or equivalent
• 1 year on site monitoring is a plus, but not a requirement

If you are interested, please send us your CV and motivation and get in touch with us at hr@clinitude.com

Clinical Data Management Lead (CDM Lead) – Cebu

At Clinitude we are looking for a CDM Lead for our office in Cebu, the Philippines.  The CDM Lead at Clinitude manages the end-to-end delivery of services related to data management for several projects.  The CDM Lead will need ensure quality deliverables on time and within budget and to customer satisfaction.  The CDM Lead provides leadership and vision to the team in the areas of project planning, execution and close out.  The CDM Lead will need to comply with Good Clinical Practices (GCP), ISO14155, applicable regulatory guidelines, SOPs, policies and where applicable, CDM guidance documents.

Read more “Clinical Data Management Lead (CDM Lead) – Cebu” →