Study Start Up Manager, With Veeva Vault CTMS

STUDY START UP MANAGER, WITH VEEVA VAULT CTMS WILMINGTON, DE Onsite in Wilmington, DE. Will consider remote for right candidate. Project Description:

• The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the client's procedures, documents, local and international guidelines such as ICH Google Cloud Platform and relevant regulations.
• The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
• The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process.
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
• Actively participates in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-Google Cloud Platform, client's SOPs and local requirements.
• Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-Google Cloud Platform prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with client's SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
• Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Support SMM in different initiatives (local, regional, or global) as agreed with the SMM Line Management.

• Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
• Good knowledge of international guidelines ICH-Google Cloud Platform as well as relevant local regulations, basic knowledge of GMP/GDP .
• Basic understanding of drug development process .
• Good collaboration and interpersonal skills.
• Good verbal and written communication skills.
• Excellent attention to details.
• Excellent understanding of Clinical Study Management and study start-up .
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
• Good medical knowledge and ability to learn relevant client's Therapeutic Areas.
• Integrity and high ethical standards.
• Good analytical and problem-solving skills.
• Good financial management skills.
• Basic change management skills.
• Good intercultural awareness.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Good cultural awareness.
• Team oriented and flexible, ability to respond quickly to shifting demands and opportunities.
• Study startup management experience, Veeva Clinical Vault CTMS, project management skills, site management skills; strong communication and organizational skills.