Senior Study Start-up Lead

hace 2 meses

Madrid, España Caidya A tiempo completo

**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 kick-off 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 project-related training is completed prior to performing any project activities as detailed by relevant SOPs
- Operationally manage Country Specialists to ensure real-time 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 out-of-scope activities in real-time.
- 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 department-level 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 start-up/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 1-year experience leadership experience in a global capacity
- Experience in Sales Support efforts for SSU (Proposals, Bid Defenses)
- Experience with study-level 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 start-up 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 pro-actively
- 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

LI-IM1

LI-Remote

The company will not accept unsolicited resumes from third party vendors.

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