# Clinical Research Manager

**Company**: Fortrea
**Location**: Bucharest
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bucharest/Associate-Project-Manager--Startup---Sponsor-Dedicated_265205?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0ba484ff-1e4

## Description

We are seeking a Clinical Research Manager to oversee the execution of local operational clinical trial activities in a country operations setting. You will have ownership and impact on local regulatory and financial compliance. Your role will significantly influence the delivery of country-specific trial commitments and objectives, particularly during study start-up.

**Key Responsibilities:**

- Financial management: assistance with country and site budgets, delivering clinical and financial contracts within fair market value, tracking payments, and reconciliation at study close-out

- Country submissions and local language materials: responsible for country submissions and approvals, development of local language materials, including Informed Consents and translations

- Management and quality oversight: manage country deliverables, timelines, and results, contribute to local SOPs development

- Collaboration: work with internal teams, vendors, sites, IRB/IECs, and Regulatory Authorities to ensure country deliverables are met

- Local process oversight: manage clinical and ancillary supplies, importing and exporting requirements, and insurance process management

**Requirements:**

- University/college degree in life sciences or related field, or certification in a related allied health profession

- Relevant clinical research experience in pharmaceutical or CRO industries, or healthcare setting

- Thorough knowledge of ICH Guidelines and GCP, regulatory requirements, and drug development process

- Fluent in local office language and English, both written and verbal

**Preferred Qualifications:**

- Good organisational and time management skills

- Working knowledge of ICH, FDA, local regulatory requirements, and IRB/IEC guidelines

- Excellent communication skills, oral and written

- Self-motivation with the ability to work under pressure to meet deadlines

**What We Offer:**

- Competitive salary

- Opportunity to work with a leading clinical trial services provider

## Skills

### Required
- ICH Guidelines
- GCP
- regulatory requirements
- drug development process
- clinical research

### Nice to have
- organisational skills
- time management
- communication skills
- self-motivation

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bucharest/Associate-Project-Manager--Startup---Sponsor-Dedicated_265205?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)