Site Activation Managers, Sponsor Dedicated. Oncology Exp Essential. Homebased

6+ years

Not Disclosed

Remote - Europe

10 Jan. 16, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Site Activation Manager - Sponsor Dedicated (Oncology Experience Essential)

Updated: Yesterday
Location: Romania (ROU) - Home-Based
Job ID: 25001112

Position Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization that focuses on accelerating customer success. Our Clinical Development model is designed to place the customer and patient at the center of everything we do, continuously striving to simplify processes and create value for both our clients and employees.

At Syneos Health, you'll work alongside passionate problem-solvers and contribute to accelerating the delivery of therapies that change lives.

WORK HERE MATTERS EVERYWHERE.

Why Join Syneos Health?

Career Development: We invest in career growth with opportunities for training, recognition, and advancement.
Inclusive Culture: Our Total Self culture encourages authenticity and inclusion, ensuring everyone feels they belong.
Engaged Leadership: A supportive and collaborative work environment, fostering engagement and innovation.

Key Responsibilities

Collaboration & Oversight
- Work with various functional areas, such as Business Development, Project Management, and Clinical teams, to ensure smooth project execution.
- Address issues around site start-up, regulatory pathways, and patient enrollment.
Site Start-Up & Maintenance
- Oversee site identification, start-up activities, regulatory submissions, and the collection of essential documents for site activation.
- Manage project timelines, ensuring alignment with milestones and mitigating any risks or delays.
Budget & Resource Management
- Review project budgets and ensure proper allocation of resources to maintain project profitability.
- Address out-of-scope work and track its resolution with the project manager.
Documentation & Quality Control
- Prepare clinical trial documentation and manage amendments throughout the lifecycle of the project.
- Perform regulatory impact assessments and provide risk mitigation strategies.
Continuous Improvement
- Contribute to internal changes and improvements across the Site Start-Up department.

Qualifications

Education: Bachelor's degree required (higher degree preferred).
Experience:
- Minimum 6 years in CRO or 5 years in SSU/clinical trial environments.
- In-depth knowledge of Phases II-IV clinical trials, ICH GCP, and EU CTR.
Skills:
- Strong project management, organizational, and vendor management skills.
- Excellent communication, problem-solving, and negotiation abilities.

Why Syneos Health Stands Out

With a strong track record of working with 94% of FDA-approved drugs and 95% of EMA-authorized products in the past five years, Syneos Health is committed to transforming clinical trials and driving success.

Additional Information

This job description may evolve as tasks and responsibilities are assigned. Syneos Health is committed to equal opportunity and provides reasonable accommodations as needed.

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Site Activation Managers, Sponsor Dedicated. Oncology Exp Essential. Homebased

Job Description

Site Activation Manager - Sponsor Dedicated (Oncology Experience Essential)

Position Overview

Why Join Syneos Health?

Key Responsibilities

Qualifications

Why Syneos Health Stands Out

Additional Information

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