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

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

AI generated summary

  • You need a bachelor's degree, 6 years CRO experience, strong understanding of trial processes, vendor management, and excellent communication skills. Oncology experience is essential.
  • You will oversee site start-up activities, manage timelines and budgets, ensure regulatory compliance, and collaborate with teams to meet quality standards and client expectations in oncology trials.

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.

Is this position home-based?

Yes, this position is home-based.

What type of organization is Syneos Health?

Syneos Health is a leading fully integrated biopharmaceutical solutions organization.

How many years of CRO industry experience are required for applicants?

A minimum of 6 years of CRO industry experience is required, or a combination of education and experience that provides the necessary knowledge and skills.

What specific degree is preferred for this role?

A Bachelor's Degree is required, with a Higher Degree preferred.

What are some key responsibilities of the Site Activation Manager?

Key responsibilities include overseeing project start-up deliverables, developing and managing integrated site start-up timelines, and ensuring all project deliverables meet internal and customer expectations.

What skills are essential for candidates applying for this position?

Essential skills include strong organizational abilities, excellent communication skills, negotiation skills, problem-solving skills, and quality-driven management.

Are there opportunities for career development at Syneos Health?

Yes, Syneos Health is passionate about developing its people through career development and progression opportunities.

Will the Site Activation Manager interact with other functional areas?

Yes, the Site Activation Manager will collaborate with various functional areas such as Business Development, Clinical, Data Management, and Medical Writing.

How does Syneos Health address employee diversity and inclusion?

Syneos Health is committed to building a diverse workplace and creating a culture where everyone feels they belong.

What types of clinical trial processes should candidates be familiar with?

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

Is vendor management experience a requirement for this position?

Yes, good vendor management skills are required.

Does the position include oversight of regulatory activities?

Yes, the position includes oversight of start-up and lifecycle maintenance regulatory activities.

What is the overall goal of the Site Activation Manager role?

The overall goal is to ensure efficient site activation and successful patient enrollment, leading to the timely delivery of therapies.

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.