# Study Start Up Manager

**Company**: IQVIA Biotech
**Location**: Lisbon, Portugal
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Lisbon-Portugal/Study-Start-Up-Manager---IQVIA-Biotech---Portugal_R1578914?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/study-start-up-manager-197d458b-cb0/

## Description

We are seeking a seasoned clinical research professional to join IQVIA Biotech as a Study Start Up Manager. You will lead the strategic planning and execution of site activation and maintenance activities across complex, global clinical studies and multi-protocol programs.

**Responsibilities:**

- Lead and oversee global site activation and maintenance activities for assigned clinical studies and programs.

- Develop and execute regulatory and site activation strategies that ensure timely study start-up and ongoing compliance.

- Partner closely with cross-functional study teams, clients, and country/regional stakeholders to achieve project milestones.

- Provide expert regulatory guidance and intelligence to support business development, bid defense activities, and study execution.

- Manage project scope, timelines, budgets, resources, and quality standards throughout the study lifecycle.

- Identify regulatory risks and challenges, developing innovative and practical solutions to accelerate study delivery.

- Oversee maintenance of clinical study approvals, essential documents, contracts, and regulatory submissions.

- Mentor and coach colleagues, fostering development and promoting operational excellence across teams.

- Build and maintain strong relationships with sponsors and key stakeholders while serving as a trusted subject matter expert.

**Requirements:**

- Bachelor's Degree in Life Sciences or a related discipline.

- Minimum of 7 years of experience within a scientific, clinical research, regulatory affairs, or site activation environment.

- Demonstrated experience working in global or international clinical research programs.

- Strong understanding of the clinical trial lifecycle, drug development process, and regulatory requirements.

- Expertise in Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory frameworks.

- Proven leadership experience with the ability to motivate, mentor, and influence others.

- Excellent project management, organizational, and financial management skills.

- Strong negotiation, communication, presentation, and stakeholder management abilities.

- Ability to manage multiple priorities and deliver results within complex, fast-paced environments.

- Proficiency with clinical systems, databases, CTMS platforms, and project tracking tools.

**Benefits:** No specific benefits mentioned.

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## Skills

### Required
- Good Clinical Practice (GCP)
- International Council for Harmonisation (ICH) guidelines
- clinical research
- regulatory affairs
- site activation
- project management
- leadership

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Lisbon-Portugal/Study-Start-Up-Manager---IQVIA-Biotech---Portugal_R1578914?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)