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

6+ years

Not Disclosed

Croatia

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: Croatia (HRV) - Home-Based
Job ID: 25001112

Position Overview

Syneos Health® is a global biopharmaceutical solutions provider committed to accelerating customer success. By integrating clinical, medical affairs, and commercial insights, we aim to address modern market challenges and streamline healthcare delivery.

Our Clinical Development model puts the customer and patient at the core of everything we do. We continuously strive for excellence by simplifying processes and promoting collaboration to drive meaningful results.

WORK HERE MATTERS EVERYWHERE.

Why Join Syneos Health?

Career Development: We offer various growth opportunities through continuous learning, leadership training, and recognition via our Total Rewards Program.
Inclusive Environment: Our Total Self culture celebrates authenticity and inclusivity, encouraging diverse perspectives that foster innovation.
Employee Wellbeing: We are committed to providing a workplace where employees feel supported and valued.

Key Responsibilities

Cross-Functional Collaboration
- Work closely with teams like Business Development, Project Management, Clinical, Data Management, and Medical Writing to ensure success across all stages of the project.
- Evaluate and resolve issues related to site start-up, regulatory processes, and patient enrollment.
Site Start-Up & Project Lifecycle Management
- Oversee site identification, regulatory submissions, and all necessary documents to activate sites.
- Manage project timelines and adapt to amendments or changes that impact delivery.
Budget Management & Resource Allocation
- Ensure the project stays within budget by tracking progress against milestones and making necessary adjustments.
- Address out-of-scope work requests and ensure they are properly documented and assigned.
Document and Regulatory Compliance
- Prepare key clinical trial documents, manage regulatory submissions, and ensure all compliance requirements are met.
- Perform risk assessments for regulatory documents and coordinate with project teams to address any gaps.
Continuous Improvement Initiatives
- Participate in process improvement initiatives within the Site Start-Up department to enhance performance and quality.

Qualifications

Education: Bachelor's degree (higher degree preferred).
Experience:
- Minimum of 6 years in the CRO industry or 5 years in a clinical trial environment, with in-depth knowledge of Phases II-IV trials, ICH GCP, and EU CTR regulations.
Skills:
- Strong project management experience in fast-paced environments.
- Excellent communication, organizational, negotiation, and problem-solving abilities.
- High attention to detail and quality management expertise.

Why Syneos Health is a Great Choice

With a track record of working on 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the last five years, Syneos Health is at the forefront of medical innovation. We have facilitated over 200 studies, across 73,000 sites, involving more than 675,000 trial patients globally.

Additional Information

The job responsibilities outlined here may be subject to change. Syneos Health is committed to diversity and equality in the workplace, and reasonable accommodations are provided to help employees perform essential job functions.

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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 is a Great Choice

Additional Information

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