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Study Start Up Manager, With Veeva Vault CTMS

Wilmington, DE

Posted: 02/14/2023 Job Number: 23109203

Job Description

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 GCP 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-GCP, 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-GCP 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.

Required Skills:
  • Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
  • Good knowledge of international guidelines ICH-GCP 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.

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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