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Sponsor Dedicated Global Project Manager Ii - Home Based In Spain

3+ years
Not Disclosed
10 Nov. 29, 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

Sponsor Dedicated Global Project Manager II (Home-Based in Spain)

Company: Syneos Health
Location: Home-based in Spain


About Syneos Health

Syneos Health is a global leader in biopharmaceutical solutions, committed to accelerating customer success through clinical, medical, and commercial insights. Their mission is to make a positive impact on patients' lives by simplifying the process of drug development, putting the customer and the patient at the center of their operations.

With over 29,000 employees across 110 countries, Syneos Health collaborates with the pharmaceutical industry to deliver therapies more quickly, efficiently, and effectively.


Why Syneos Health?

  • Career Development: Syneos Health offers ample opportunities for career progression, through career development programs, training, and peer recognition.
  • Inclusive Culture: With a Total Self culture, Syneos Health supports diversity and inclusivity, ensuring everyone feels like they belong.
  • Global Impact: Over the past 5 years, Syneos Health has contributed to 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products.

Role Overview

As a Sponsor Dedicated Global Project Manager II, you will oversee global clinical studies from initiation to closeout. You will be responsible for managing interdisciplinary teams, ensuring compliance with regulatory requirements, and delivering studies on time and within budget. This position requires global project management experience, and experience with Phase I or Phase IV studies is preferred.


Key Responsibilities

Project Leadership and Delivery

  • Project Management: Lead global clinical research studies, ensuring they are conducted according to GCP, SOPs, and regulatory requirements.
  • Liaison Role: Act as the primary contact between the company and the customer, ensuring the study meets contractual milestones and quality standards.
  • Team Leadership: Oversee project teams, ensuring quality, timelines, and budget management.
  • Financial Oversight: Manage financial aspects of the project, ensuring it stays within budget.

Documentation and Reporting

  • Quality Control: Ensure the quality and completeness of the Trial Master File (TMF) for assigned studies.
  • Data Management: Oversee study data across various databases, maintaining accurate and up-to-date records.
  • Risk Management: Develop contingency plans and risk mitigation strategies to address challenges and ensure the successful delivery of study goals.
  • Meetings and Presentations: Plan, coordinate, and present at internal and external meetings, providing status updates and reports.

Business Development

  • Client Relations: Build and maintain strong relationships with current clients to drive new business opportunities.
  • Bid Defense Participation: Represent Syneos Health in bid defense meetings to secure new projects.

Management Responsibilities

  • Team Management: Potentially line manage other project management team members and clinical monitoring staff.

Qualifications

Education and Experience

  • Degree Requirement: A Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field, or equivalent combination of education and experience.
  • Project Management Experience: Significant experience in global study management and project management, with knowledge of Phase I and/or Phase IV studies.
  • Clinical Research Knowledge: Background in Clinical Research Organizations (CROs) with expertise in therapeutic areas and strong knowledge of GCP, ICH guidelines, and regulatory requirements.

Skills

  • Project Management: Exceptional organizational skills, with the ability to manage multiple projects, timelines, and priorities effectively.
  • Leadership: Ability to lead cross-functional teams and ensure collaboration across study stakeholders.
  • Communication: Strong verbal and written communication skills, with experience in client-facing interactions.
  • Adaptability: Comfortable with new technologies and fast-paced work environments.

Additional Requirements

  • Travel: Willingness to travel up to 25% for site visits and meetings as needed.

Compensation & Benefits

  • Salary Range: Competitive, based on experience and qualifications.
  • Benefits: Comprehensive health benefits, 401(k), flexible paid time off (PTO), and more.

Apply Now

If you're an experienced global project manager with a passion for clinical research and want to join a company that’s making a global impact, apply today to join Syneos Health!

Note: Syneos Health is committed to diversity and inclusion and encourages all qualified candidates to apply, regardless of their background or experience.