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Site Activation Managers, Sponsor Dedicated. Oncology exp essential. Homebased

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Syneos Health Commercial Solutions

22d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Madrid

AI generated summary

  • You need a Bachelor's (higher preferred), 6+ years in CRO or SSU, strong project and vendor management skills, and a deep understanding of clinical trial processes, protocols, and GCP.
  • You will oversee site start-up activities, manage timelines and budgets, ensure client satisfaction, and collaborate across teams to achieve regulatory compliance and successful patient enrollment.

Requirements

  • Bachelor's Degree, Higher Degree Preferred. Minimum 6 years CRO industry experience and/or a minimum 5 years' experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP & EU CTR
  • Good understanding clinical protocols and associated study specifications.
  • Excellent understanding of clinical trial start-up processes.
  • Project management experience in a fast-paced environment.
  • Good vendor management skills
  • Strong organizational skills with proven ability to handle multiple projects.
  • Excellent communication, presentation and interpersonal skills.
  • Quality-driven in all managed activities.
  • Strong negotiating skills.
  • Strong problem-solving skills.
  • Demonstrate an ability to provide quality feedback and guidance to peers.

Responsibilities

  • Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
  • Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.
  • Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management.
  • Develops and maintains relationships with customers in alignment with their assigned projects.
  • Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
  • Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects.
  • Assumes accountability on start-up deliverables including, but not limited to:
  • Site Identification and selection
  • Start-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions)
  • Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any require amendments
  • Establishing and overseeing Essential Document collection leading to site activation
  • Overall SSU timelines, prior to and following site activation. Including any realignment required due to amendment needs.
  • Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.
  • Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
  • Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
  • Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.
  • Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.
  • Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects.
  • Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.
  • Responsible for or assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.
  • Oversees collation, quality review, and submission of country-specific applications.
  • Contributes to change initiatives across and within the SSU department.

FAQs

What is the job title for this position?

The job title is Site Activation Manager, Sponsor Dedicated.

Is oncology experience required for this role?

Yes, oncology experience is essential for this position.

Where is this position based?

This position is home-based.

What qualifications are needed for the Site Activation Manager role?

Candidates should have a Bachelor's Degree (Higher Degree preferred) and a minimum of 6 years of CRO industry experience or at least 5 years in a Site Start-Up (SSU) or clinical trial environment.

What are the primary responsibilities of a Site Activation Manager?

The role involves overseeing project start-up deliverables, ensuring compliance with regulatory requirements, managing relationships with customers, and maintaining high-quality standards throughout the project lifecycle.

What type of work environment can I expect?

The work environment is fast-paced and requires collaboration with various functional areas, including project management, clinical data management, and vendor management.

What skills are important for this role?

Important skills include strong organizational abilities, excellent communication and interpersonal skills, project management experience, vendor management skills, and strong problem-solving capabilities.

What kind of company culture does Syneos Health promote?

Syneos Health promotes a Total Self culture, emphasizing inclusivity, diversity, and the development of its employees.

Will I be expected to manage multiple projects at once?

Yes, the role requires the ability to handle multiple projects simultaneously while maintaining high quality and efficiency.

Are there opportunities for career development at Syneos Health?

Yes, Syneos Health is passionate about developing its employees through career development and progression programs.

Does this position involve client interactions?

Yes, the role involves developing and maintaining relationships with customers and presenting overall site start-up strategies at client meetings.

What is the expected level of experience with clinical trial processes?

Candidates should have an excellent understanding of clinical trial processes across Phases II-IV, as well as ICH GCP and EU CTR guidelines.

What tools or practices will be used for project management?

Candidates are expected to use professionally recognized tools and practices for planning and management of scope, timelines, and resources effectively.

Is the job description exhaustive, or might other responsibilities be assigned?

The job description is not exhaustive, and additional tasks, duties, and responsibilities may be assigned at the company's discretion.

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Syneos Health Commercial Solutions

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.