Senior Study Start-up Lead - Madrid, España - Caidya

Caidya

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Job Title:
Senior Study Start-Up Lead (SSUL)

Job Location:

Madrid, Spain
Job Overview:

Job Duties and Responsibilities:

Act as a SSU lead for the assigned countries and regions, participating directly at kickoff meetings, sponsor calls, providing the client with procedural and legal guidance, and study updates and advice as how to respond to IRB/EC and CA/MOH questions and requests.
Perform risk management to ensure early risk identification and create appropriate mitigation plans, as well as document related risks.
Prepare and support the forecast of all SSU milestones and intermediate steps. Oversee the execution to achieve the contracted milestones.
Operationally manage Country Specialists appointed to the project, ensuring their projectrelated training is completed prior to performing any project activities as detailed by relevant SOPs
Operationally manage Country Specialists to ensure realtime reporting of metrics into reporting systems, including planned and actual data. May be responsible to report on progress to the internal and client teams.
Review and approval of CA/EC Country submission dossier, including queries and amendment management.
Inform project team about amendment approvals for immediate implementation.
Accountable for Annual Progress Report submission, End of Trial notification, Clinical Study Report submission, as applicable.
Is responsible for the operational performance of the reporting project team, escalating issues to the appropriate Line Manager.
Works closely with Clinical Contracts to ensure oversight of provision of Clinical Trial Agreements and budget templates for the participating sites in a timely manner and their timely execution.
Promote financial health of the Company by realizing units for assigned studies/programs, reviewing planned and actual milestones, and raising risks to any deviations. Review study level budget and raises outofscope activities in realtime.
May participate in RFI/RFP processes, bid defences, initial business development meetings with prospective clients, proposal development, and other business development activities as requested.
Demonstrate flexibility, patience, strong attention to details, and leadership by example.
Confidently operate in electronic databases and systems such as electronic Trial Master Files, time recording, authority, and IRB/EC electronic document upload and submission systems.
May be called upon to conduct training and departmentlevel initiatives.

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education

A minimum of Bachelor of Science in life sciences, pharmacist, M.Sc., or Doctorate in sciences preferred.

Experience

A minimum of 5 years working in startup/regulatory affairs for clinical trials, as well as previous CRO experience
Minimum 2 years of proven leadership experience in the leading or supporting role
Minimum 1year experience leadership experience in a global capacity
Experience in Sales Support efforts for SSU (Proposals, Bid Defenses)
Experience with studylevel financial management
Working knowledge of regulations: Has expertise to work in accordance with local guidelines (provided by SSU groups in each country).
Experience in training or mentorship preferred

Skills/Competencies

Analytical: Synthesizes complex or diverse situations
Strong written and verbal communication skills; speaks clearly, listens, and reacts calmly; and understandably communicates with sponsors and internal team members who may not be familiar with regulatory and startup requirements and processes
Ability to identify risks and propose solutions in a timely manner
Proactively suggests quality improvements to procedures and electronic systems to promote accuracy and compliance.
Sound judgment: displays willingness to make decisions, exhibits sound and accurate judgment, and makes timely decisions.
Ability to problem solve and work independently and proactively
Prioritizes and plans work activities, uses time efficiently, and develops realistic action plans.
Demonstrates flexibility and willingness to learn new skills
Comprehensive knowledge of ICH/GCP
Strong attention to details

Capabilities

Windows; proficient in MS Word, Excel, and Powerpoint
Experienced in utilizing regulatory intelligence databases
Excellent organizational skills
Exceptional English written and oral communication skills, proficiency in other languages is an advantage
Excellent personal interaction skills
Excellent team player with leadership capabilities

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