OPEN POSITIONS

JOB DESCRIPTION

Acts as primary individual responsible for monitoring activities with investigational sites, from site identification and selection, through site activation, subject enrolment and study conduct until close out, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and any applicable regulations and SOPs.

Requirements:

• Bachelor’s degree in health care or life science related field
• At least 12 months proven monitoring experience
• Strong knowledge of ICH GCP Guidelines and other applicable regulatory requirements
• Fluent written and spoken English
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills
• Willing to travel approximately 40-60% nationally

Primary Location:

Timisoara or Bucharest, Romania
Availability for office/home based position.

Employment Type: Full-time

What to expect next:

We look forward to receiving your application (in English).
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

JOB DESCRIPTION

Purpose of Job: Direct and line manage all Accelsiors clinical operations staff in all countries where Accelsiors operates to ensure satisfactory conduct and compliance of all studies for which Accelsiors is contracted to perform monitoring, clinical data review, study feasibility, study set-up and patient / site recruitment activities.

The Executive Director of Clinical Operations actively participates in projects and interacts with the CEO, Global Project Management, Biometrics management, Business Development and the Proposals team to ensure the Company achieves maximum performance, quality standards and overall financial targets.

Requirements:

• Bachelor’s level degree
• At least 5 years’ experience in Clinical Trials
• Strong management experience in CRO at international level
• Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good knowledge of applicable legislation
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Detail oriented
• Must demonstrate good computer skills
• Ability to provide clear direction and guidance to others
• Good level of English knowledge (written and spoken)

JOB DESCRIPTION

The role of the Executive Director QA is to oversee the Company’s full Quality Management System and providing the Company’s Senior Management assurance that this system meets global regulatory requirements, provides output and documentation needed to support the goals and objectives of the company and enables Accelsiors to effectively work with Clients, Client’s Vendors and Accelsiors Subcontractors. It is a technical and leadership position reporting to the CEO.

Requirements:

MS/BS degree in Scientific Discipline/ Life Sciences preferred

Strong experience in Clinical or GMP or GLP Quality Assurance

Thorough knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit procedures and reporting

Capable of writing Quality Management Documents, effective SOPs, Quality Assurance Reports and training materials

Core competencies: Management skills, communication, flexibility, positive attitude, customer service, planning & organizing, relationship building, problem solving & decision making.