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Project Manager Ii - Early Phase ** Sponsor Dedicated - Homebased Spain ** Immunology & Inflammation Experience Required

10 Dec. 2, 2024
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

Project Manager II – Early Phase

Sponsor Dedicated – Home-Based Spain
Immunology & Inflammation Experience Required
Updated: November 27, 2024
Location: Spain (Home-Based, Madrid)
Job ID: 24006116


Role Overview

Syneos Health seeks a Project Manager II with expertise in Immunology & Inflammation to manage early-phase clinical trials in a sponsor-dedicated, home-based capacity in Spain. This role requires strong project management skills, regulatory knowledge, and the ability to lead cross-functional teams to ensure successful delivery of study objectives.


Core Responsibilities

Project Leadership and Execution

  • Manage interdisciplinary clinical research projects ensuring adherence to GCP, SOPs, and regulatory requirements.

  • Act as the primary liaison between Syneos Health and the sponsor, ensuring timely and effective study execution.

  • Oversee project teams, ensuring studies are completed on time, within budget, and meet quality expectations.

  • Monitor financial performance and proactively address potential issues.

  • Develop and implement risk mitigation strategies to address study challenges.

Documentation and Reporting

  • Ensure high-quality documentation for Trial Master Files (TMF) and maintain study information in required databases and systems.

  • Provide timely and accurate project updates to clients and senior management.

  • Oversee study plans and ensure inspection readiness at all times.

Business Development and Collaboration

  • Build and maintain strong sponsor relationships to foster ongoing and future collaborations.

  • Represent the company during bid defense meetings when proposed as project lead.

Leadership and Mentorship

  • Support and guide team members, offering mentorship to junior project managers or clinical staff.

  • Promote collaboration and adherence to best practices within the team.


Candidate Profile

Essential Qualifications

  • Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or an equivalent field.

  • Experience managing early-phase clinical studies, particularly in Immunology & Inflammation.

  • Strong knowledge of GCP/ICH guidelines and clinical trial regulatory requirements.

Key Skills

  • Exceptional organizational and time-management abilities.

  • Strong technical proficiency and ability to adopt new technologies.

  • Excellent communication, interpersonal, and presentation skills.

  • Ability to manage projects independently and multitask in a fast-paced environment.

  • Willingness to travel up to 25% of the time.


Why Join Syneos Health?

Global Impact

  • Contribute to innovative projects involving 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the last five years.

Career Growth and Development

  • Access a robust program for career progression, peer recognition, and therapeutic training.

  • Thrive in a Total Self culture, promoting authenticity, inclusivity, and professional growth.


Application Information

Are you passionate about driving early-phase clinical trials to improve patient outcomes? Apply now or join the Talent Network to explore more opportunities with Syneos Health.