Senior Manager, Study Start Up
Alexion Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Coordination and administration of start-up activities of clinical studies from site identification through site activation
- Obtain and maintain essential documentation in compliance with ICH-GCP, Alexion/AstraZeneca Procedural Documents.
- Under supervision from the PMCO/HCO and other relevant stakeholders (i.e. Legal, ClinOps, etc.), assist in negotiations of budget and contract with site resolution of issues and contract execution.
- Assists in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.
- Extensive interactions with Health Authorities in assigned countries or regions to facilitate the submission and queries to ensure successful country approval.
- May be responsible for multiple countries, ensuring successful submission strategy and execution where needed.
- Coordinates with relevant stakeholders to generate responses to Ethics/IRB, RA queries during the evaluation period of the study; proceeds with submission of the responses within timelines
- Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC/IRBs within the country; includes safety notifications as required by local regulations, working with local study team in the country level..
- Share information (metrics) on study site progress towards activation within local study teams and Senior Management as required.
- Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan. Review and collect essential regulatory documents for filing in eTMF
- Set-up, populate and accurately maintain information in Alexion's tracking and communication tools (e.g. Veeva Vault, SharePoint etc.) and support others in the usage of these systems.
- Coordinates with other local study team members for preparation and submission of regular study progress reports
- Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per start-up process and agreement with the clinical study team
- Confirms debarment status of potential investigators
- Acts as a Sponsor local person for the regular update of local clinical trial registries according to local regulations, as applicable
- May oversee SSU associates to ensure quality and compliance throughout the study startup process
- Minimum 6 years of Study Startup experience
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of relevant local regulations in each of the countries responsible (as applicable)
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
- Basic understanding of the drug development process.
- Excellent attention to details.
- Excellent written and verbal communication skills.
- Excellent collaboration and interpersonal skills.
- Excellent negotiation skills.
- Veeva Clinical Vault Experience
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Experience at CRO or Sponsor
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.