• Working with study team and regional manager to support them with operational activities.
• Assisting study team in the ongoing planning, execution and close out of the study.
• Providing ongoing administrative support to study team members and other managers
• Supporting colleagues in tracking study progress in various studies
• Responsible for managing the study documentation (tracking, filing, collecting relevant study information)
• Ability to collaborate with Site Staff to resolve daily administrative issues.
• Assist study team in coordinating the planning start up, management and monitoring activities.
• Responsible for maintaining effective communication and working relationship with internal and external stakeholders
• Ability to work effectively in a remote environment

Skills: Operational Support, Study Execution, Admin Assistance, Progress Tracking, Documentation Management, Issue Resolution, Project Coordination, Stakeholder Communication

• Responsible for study start up and support activities
• Track study related documents
• Manage logistic and document exchange
• Identify opportunities and best practices and communicate this
• Develop, maintain and manage appropriate study documentation
• Periodic review of study files
• Central contact for the clinical team
• Assist the project management team in general
• More details will be revealed after the pre-screening

Skills: Startup Support, Document Tracking, Logistics Management, Best Practices, Documentation Development, File Review, Team Communication, Project Assistance

• Create/maintain essential document trackers
• Conduct comprehensive review, as per Trial Master File (TMF) Plan
• Provide continuous input to electronic Trial Master File (eTMF) content list
• Assist with Clinical Operations internal filing of study documents in Livelink/O365 and eTMF
• Facilitate the initiation and maintenance of the Clinical Trial Agreements, non-disclosure agreements, contract execution, vendor purchase orders, and miscellaneous study requests in Spring CM, as needed
• Reconciliation & management of key documents (plans, site contact list, etc.)
• Assist in any purchase order (PO) related inquiries
• Assist in any subject travel inquiries, escalations, or exceptions
• Ensure vendor PO contains funds for insurance and translation vendors
• Ensure invoice management for insurance and translations 

Skills: Document Tracking, TMF Review, eTMF Input, Internal Filing, Agreement Facilitation, Document Reconciliation, PO Inquiries, Invoice Management

• Reporting to the Associate Director, Clinical Operations, the Clinical Trial Assistant III is a senior level CTA who provides administrative and project-specific support related to the conduct of clinical trials and archiving of clinical trial documentation.
• Process clerical and study management tasks
• Attend clinical study team and departmental meetings
• Assist in coordinating study management processes
• Assist with the development of tracking tools and processes that increase measured efficiencies of the clinical study
• Participate in study startup process including review and development of study-related documents and tools including but not limited to site regulatory packages, study manuals, and instructions
• Support and work with CRAs and CTMs
• Serve as a resource for and interact with other functional areas and departments to facilitate achieving project-specific tasks
• Comply with departmental SOPs and GCP/ICH guidelines
• Provide administrative support to the Clinical Development team, up to 15% as needed
• Participate in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines
• Assist in preparation and QC of Clinical Study Reports
• Facilitate flow and maintenance of correspondence with contract service providers (CSPs) and investigative sites
• Record minutes during meetings with CSPs and investigators
• Prepare communication for mass distribution

Skills: Administrative Support, Study Management, Meeting Participation, Process Coordination, Tool Development, Study Startup, Cross-functional Collaboration, Document Preparation

• Draft project-related documents for employees within the depot and logistic areas to ensure adequate handling of shipments
• Contribute to the overall set-up of the trial by creating work instructions and building protocols
• Ensure key study deliverables are maintained in accordance with study contracts
• Dealing with project inquiries, preparation and maintenance of study reports and KPIs
• Assisting in client audits, developing SOPs and project forecasting.
• Lead technical and design discussions with IT executives to help enterprises speed their adoption of new technologies and practices
• Advise on implementing AWS best practices
• Influence infrastructure architecture by sharing application development expertise
• Work as a technical leader alongside customer business, development and infrastructure teams
• Leverage new technology paradigms (e.g., serverless, containers, microservices)
• Refactor monolithic applications to micro services architectures

Skills: Document Drafting, Protocol Creation, Deliverable Maintenance, Report Preparation, Audit Assistance, Technical Leadership, AWS Best Practices, Architecture Influence

• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail
• Excellent written and verbal communication skills
• Relevant clinical trial experience or equivalent.
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Perform activities in a timely and accurate manner.

Qualifications: BA in Public Health with 3 years of Experience

• Familiarity and experience working with eTMF applications
• Recognition and understanding of clinical research documents, their contents, and purpose
• Strong understanding of GCP and knowledge of regulatory requirements
• Clinical Research or CRO/Biotech experience 
• Solid knowledge of clinical trial processes and ICH/GCP guidelines
• Well organized with good time management skills
• Strong ability to work in cross-functional teams
• Excellent communication skills
• Strong skills in Microsoft Office (Excel, PowerPoint, Word...)
• Dynamic and closely interacting R&D team in an agile working environment
• Flexible hours and home office opportunities

Qualifications: BA in Psychology with 5 years of Experience

• Experience in the biotech industry and clinical drug development or clinical trial execution
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Demonstrates well-developed instincts and problem-solving skills
• An understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
• Experience in Hematology/Oncology, Neurology, Immunology, Opthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy
• Strong communication, organizational and interpersonal skills are required
• Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
• Strong understanding of clinical efficacy and safety data, interpretation of tables and listings, and analysis to ensure clinical data integrity

Qualifications: BS in Clinical Research with 4 years of Experience

• Proficient in English, spoken and written. 
• Knowledge of French and/or Dutch. 
• Be a team player and at the same time able to work very independently
• Have excellent communication & time management skills
• Have advanced computer skills (MS Office)
• Have an eye for detail and are meticulous, quality-minded, and efficient
• Be stress-resistant and are not afraid to take responsibility & initiative
• Proactive and eager to learn
• Like to comply with procedures and processes while applying critical thinking in the context of process improvement
• Proven ability to plan and track deliverables and timelines.
• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.

Qualifications: BS in Nursing with 6 years of Experience

• Hands-on administrative support experience or clinical research experience.
• Proficiency in O365 (Word, Excel, and Outlook).
• Experience with the Clindex EDC system
• Knowledge of operating standard office equipment.
• Excellent organizational and strong problem-solving skills.
• A conscientious person with an outstanding work ethic and strong personal discipline.
• Professional level German and English required.
• Excellent written and verbal communication skills.
• Excellent independent time management skills.

Qualifications: BS in Pharmacy with 2 years of Experience