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Clinical Trials Operations Specialist

2 maanden geleden

Amsterdam, Noord-Holland, Nederland Allucent Voltijd
Unlock Your Potential in Clinical Trials Operations

We are seeking a skilled Clinical Trials Operations Specialist to join our team at Allucent. As a Clinical Trials Operations Specialist, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibilities will include:

Key Responsibilities
  • Govern highest possible quality standards for trial monitoring activities.
  • Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
  • Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines:
  • Performs efficient site management in line with study budget.
  • Prepares and submits quality Site Visits Reports and Contact reports.
  • Maintains and updates CTMS in compliance with SOPs and study-specific directives.
  • Acts as Document Owner for collected documents.
  • Conducts co-monitoring as needed.
  • Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF).
  • Liaises with project team members and Sponsor to track study progress and milestones.
  • Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines.
  • May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
  • May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training.
  • May perform assessment visits.
  • Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel.
  • Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution.
  • Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed.
  • May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable.
  • May participate in meetings with clients.
  • May support project manager/CTL and project functional leads in the project oversight and management.
  • Supports site staff in preparation for study related site audits and inspections.
  • Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
Requirements
  • At least two years clinical monitoring experience and/or relevant clinical trial experience.
  • Relevant life science degree / medical / nursing background, or combination of education and experience.
  • Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.
  • Ability to travel for up to 8 days on site per month, depending on the project needs.
  • Strong written and verbal communication skills including good command of English and local language.
  • Representative, outgoing and client focused.
  • Ability to work in a fast-paced challenging environment of a growing company.
  • Administrative excellence
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
  • Effective clinical monitoring skills (all kind of visits mastered):
  • Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology.
  • In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
  • Excellent understanding of the drug development process.
  • Ability to proactively identify and resolve issues in a timely manner.
  • Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel.
  • Effective organizational and time management skills.
  • Ability to manage multiple projects and strong attention to detail.
  • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients.
  • Ability to meet project requirements.
  • Proven flexibility and adaptability.
  • Ability to work in a team or independently and to effectively prioritize tasks.
Salary Information

The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and location. Compensation packages will be discussed during the interview process.

Benefits

Allucent offers a comprehensive benefits package, including:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.