At ARIANNE highly motivated individuals are working as a team to make a significant impact upon our business while progressing in their careers.
Our culture is professional, team-oriented, and multi-disciplinary. We seek talented career professionals who share a passion for making a contribution to medical advancements that help improve the quality of people’s lives.
We are committed to attracting and retaining the very best people. The Company will strive to create an entrepreneurial culture to support, motivate and reward our employees as they contribute to our success.
We are committed to the highest quality business practices and to apply the highest ethical standards to our products, services and communications. Quality is a cornerstone of all of our activities. We seek the highest quality information, decisions and people. We produce high quality products and services.
Please contact us at: firstname.lastname@example.org
ARIANNE is a Clinical Research Organization that offers specialized flexible clinical management solutions with expertise through our international clinical/regulatory offices. At Arianne, highly motivated individuals are working as a team to make a significant impact upon our business while progressing in their careers.
We are currently seeking globally full-time Clinical Trial Project Managers for our USA, and international offices.
- Coordinate the activities associated with the evaluation, initiation and management of clinical trials.
- Coordinate clinical and regulatory activities with company ex-US offices.
- Lead in the selection and implementation of clinical sites.
- Contribute to the preparation of clinical protocols and amendments.
- Support the preparation and submission of regulatory reports and clinical study reports.
- Provide technical, scientific, and administrative assistance to the department.
- Manage vendors and communicate with sites and others within the company, both in, and outside the department.
- Coordinate the organization of investigator meetings.
- Assist in the design and format of CRFs, study guides and subjects leaflet.
- Track CRO and third party vendor activities.
- Identify, select, and implement clinical sites.
- Coordinate the activities associated with start up and management of clinical sites.
- Ensure budgets, schedules, and performance requirements are met.
- Monitor progress of studies identifying delays and initiation of corrective actions when necessary.
- Perform other duties as required.
- Operate to the highest ethical and moral standards.
- Comply with our policies and procedures.
- Adhere to quality standards set by regulations, and company policies, procedures and mission.
- Communicate effectively with supervisors, colleagues and subordinates. Be committed to team effort and be willing to assist in unrelated job areas when called upon.
- Provide administrative leadership for company and provide knowledge-based expertise in related areas that can be applied to meeting the strategic goals.
- Travel as needed.
Education Requirements / Experience Level:
- RN/BSN or Bachelor’s degree in a clinical or health-related field or in life sciences. A masters degree in a clinical or health-related field or in life science is preferred.
- Seven years of experience in monitoring, clinical trials management, and performing data management activities (e.g., data resolution, database lock, etc.) with a CRO, Pharmaceutical or Biotech Company
- At least 3 years of in-house experience with a CRO, Pharmaceutical or Biotech Company and previous lead/clinical trial manager experience.
We are currently seeking globally full-time Clinical Research Associates I / II/III for our USA and international offices. Under same title job, please remove space here:
- Implement and monitor clinical trials in all phases of drug development.
- Conduct pre-study, initiation, routine, and closeout visits and report findings in a site visit report.
- Act as primary contact to sites.
- Conduct quality assurance activities to assure the compliance of company SOPs, FDA and ICH guidelines of contract research organizations, study coordinators, investigators, and independent consultants.
- Communicate with sites, clinical vendors, and others within the company, both in and outside the department.
- Review and resolve discrepancies in clinical data at clinical sites and central laboratories via query process.
- Adhere to company SOPs, FDA regulations and ICH guidelines.
- Track clinical data, regulatory documents, patient enrollment, and data resolutions to assure the timely completion of clinical studies.
- Provide technical and administrative assistance to the department.
- Identify and assist in the selection and implementation of clinical sites.
- Select, design and implement the data collection method and tools with vendors.
- Assist in the creation of informed consents, case report forms, instruction manuals, Newsletter, and monitoring and tracking tools.
- Oversee delivery and shipment of clinical trial supplies and ensure accounting of usage in clinical studies.
- Perform clinical finance duties (site payments, CRO payments etc.)
- Perform other duties as required.
Education Requirements / Experience Level:
- Requires a Bachelor’s degree in a life science or RN/BSN degree, or equivalent.
- Two years of experience in monitoring, clinical trials management, and performing data management activities (e.g., data resolution, database lock, etc.) with a CRO, Pharmaceutical or Biotech Company.
- Must have excellent organizational skills and be a team player.
- Must be able to prioritize and function independently.
- Knowledge of FDA regulations and GCP required.
- Computer proficiency required.
- Must be willing to travel.
- Requires excellent verbal and written communication skills
Clinical Document Specialist
We are currently seeking a full-time Clinical Document Specialist for our USA and international offices.
This position is responsible for providing QA oversight of Clinical operations, supporting the implementation and maintenance of the Document Control and QA training development systems and ensuring compliance to applicable regulatory, FDA, and ICH guidelines/regulations.This position also supports the review of regulatory and clinical documents, as needed.
Responsibilities include, but are not limited to:
- Assist with the conduct of routine audits of clinical files to ensure that regulatory documents are collected, updated and filed appropriately.
- Ensure compliance with applicable FDA regulations and ICH guidelines
- Ensure that regulatory and clinical documents are filed, scanned, and archived according to company SOPs, regulatory commitments, and sponsor obligations
- Collaborate with project managers to ensure trial master file content and format are consistent, communicated and adhered to.
- Support the creation, implementation, maintenance and improvement of hardcopy and electronic filing systems for the retention of all clinical trial documents.
- Assist Head of QA with the preparation, review, tracking and maintenance of regulatory and clinical documents.
- Review documentation as needed to support regulatory filings
- Assist with the creation and revision of controlled documents to support and improve quality systems.
- Support, maintain, and improve QA training development systems.
- Provide clinical-specific training to company personnel.
- Assist in training company personnel on other QA aspects, as needed.
Education Requirements/Experience Level:
- Bachelors degree preferred (or equivalent knowledge, skills, experience)
- Experience in Clinical required (understanding and implementation of clinical regulations/guidelines)
- 2 to 3 years of Clinical experience required
- 1 to 2 years of Document Control experience preferred
- 1 to 2 years of training experience preferred
- Knowledge and experience with regulatory and clinical documents required
- Strong organizational skills
- Strong communication skills
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, etc) and Adobe Acrobat
- Attention to detail
- High work ethics