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

Here’s the rewritten job description with a slug included at the end:

Site Activation Manager
Location: Bulgaria-Europe (Home-Based)
Job ID: 25001112

About Syneos Health
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success. By combining clinical, medical affairs, and commercial insights, we address the ever-evolving market dynamics.

Our Clinical Development model prioritizes both the customer and the patient, aiming to simplify processes and ensure an efficient work environment for employees and clients alike. Join us to become part of a team passionate about advancing therapies that change lives.

Why Work with Us
At Syneos Health, we are deeply committed to:

Supporting career development and progression.
Providing technical and therapeutic area training.
Promoting a culture of inclusion and authenticity, where employees can truly be themselves.
Building an organization that values diversity and creates a sense of belonging.

Key Responsibilities

Collaborate with multiple functional areas including Business Development, Alliance Management, Contracts, Clinical, and Data Management.
Lead site activation efforts, including site identification, regulatory submissions, and lifecycle maintenance of clinical trials.
Identify and resolve challenges related to project start-up, regulatory pathways, and patient enrollment.
Ensure all deliverables meet contractual expectations, timelines, and quality standards.
Build and maintain client relationships, ensuring consistent communication and delivery excellence.
Oversee activities such as site agreements, investigator budgets, and essential document collection to ensure timely site activation.
Develop and manage site start-up timelines, addressing potential risks or gaps proactively.
Prepare and present site start-up strategies and progress updates to clients and internal teams.
Manage budgets to align with project milestones, taking corrective actions as necessary.
Lead the creation of regulatory documents and assess the impact of amendments, offering solutions for identified risks.
Oversee the preparation, review, and submission of country-specific applications, ensuring quality and compliance.
Drive cross-departmental change initiatives to improve site start-up processes.

Qualifications

Education: Bachelor's degree required; advanced degree preferred.
Minimum 6 years of CRO industry experience or 5 years in a Site Start-Up (SSU) or clinical trial environment.
Comprehensive understanding of clinical trial processes (Phases II-IV) and ICH GCP/EU CTR guidelines.
Expertise in clinical trial protocols, start-up processes, and project management.
Strong organizational skills and the ability to manage multiple projects simultaneously.
Excellent communication, negotiation, and interpersonal skills.
Quality-focused with a proven ability to solve problems effectively.

About Syneos Health
With extensive experience, Syneos Health has supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies at 73,000 sites involving 675,000+ patients in the past five years.

Join us and take the initiative to make a meaningful impact in a highly competitive and dynamic industry.

Additional Information
The tasks, duties, and responsibilities outlined here are not exhaustive and may be modified at the Company’s discretion. Syneos Health is committed to equal opportunity and reasonable accommodation under applicable regulations, including the EU Equality Directive and the Americans with Disabilities Act.

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

Job Description

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