Senior Study Start-Up Lead

hace 4 semanas

Madrid, España Caidya A tiempo completo

Job Overview:

The Senior Study Start-Up Lead (Sr. SSUL) will be involved in managing global and/or regional submission of global applications for clinical trials for studies executed by the Company on behalf of clients. The Sr.SSUL should be able to independently compile, review and approve CORE essential study documents and have solid understanding of the requirements for regulatory submissions for the competent authorities and ethics committees/IRBs throughout the regions where the Company conducts clinical trials. Responsibilities include oversight management of progress of ethics committees/IRB and competent authority submissions made by country experts and require technical knowledge about conduct of a clinical trial, ICH/GCP, and regional/local regulations. The Sr. SSUL should have excellent verbal and written English as well as native language communication skills. The Sr. SSUL may support training and departmental-level initiatives.


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. Prepare the CORE clinical trial application package, including review of the included documents such as the application form, protocol, IB, IMPD/Quality, and any patient-facing document, and obtain acceptance from the project manager and approval from client for the document package. This includes understanding the implication of timelines for the availability of these documents.  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. Capable of providing regional or local country procedural and legal advice/guidance to internal project members, particularly Country Specialists, either verbally, via email, training, or as a presentation. 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 detail

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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