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

Syneos Health Commercial Solutions

21d ago

Job
Full-time
Senior Level
Research & Development
Healthcare
Madrid

AI generated summary

You need a Bachelor's degree, 6+ years in CRO or clinical trials, strong project management and vendor skills, excellent communication, and problem-solving abilities, with oncology experience essential.
You will oversee site start-up activities, manage timelines and budgets, collaborate with teams, ensure deliverables meet standards, and maintain regulatory compliance for oncology projects.

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

Is oncology experience required for this position?

Yes, oncology experience is essential for this role.

What is the job title for this position?

The job title is Site Activation Manager, Sponsor Dedicated.

Is this position home-based?

Yes, this position is home-based.

What qualifications are necessary for this job?

A Bachelor's degree is required, with a minimum of 6 years of CRO industry experience or 5 years in a Site Start-Up or clinical trial environment.

What specific skills are desired for applicants?

Desired skills include project management, vendor management, strong organizational skills, excellent communication skills, problem-solving abilities, and strong negotiating skills.

Will I need to collaborate with other teams in this role?

Yes, you will collaborate with various functional areas including Business Development, Project Management, and Clinical teams.

What are the main responsibilities of a Site Activation Manager?

Responsibilities include managing site selection and activation, ensuring project deliverables meet expectations, and maintaining relationships with customers, among others.

How important is project management experience for this position?

Project management experience is crucial, particularly in a fast-paced environment.

Does Syneos Health have a culture focused on employee development?

Yes, Syneos Health is passionate about developing employees through career development, training, and recognition programs.

Are there diversity and inclusion initiatives at Syneos Health?

Yes, Syneos Health is committed to building a diverse workplace where everyone feels they belong.

Will the role involve oversight of regulatory activities?

Yes, oversight of regulatory activities related to site start-up will be a significant part of the role.

Is there an emphasis on quality in the work performed by the Site Activation Manager?

Yes, a strong focus on quality is required in all managed activities.

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.