The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements.
The CSA collaborates closely with the Project Manager Country Operations (PMCO) and other local study team members in COM such as Study Start Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country.
You will be responsible for:
Providing support to the local study team in COM in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)
End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials.
Providing support to the local study team including for start up activities in start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation and preparation and approval of sites for activation, etc
Collaborating with PMCO, CRAs, SSU manager and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information
Act as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation.
Input on the development and maintenance of project management and other global tracking tools (e.g: CTMS, smartsheets, etc).
Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs)
Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region.
Providing support to local COM team with local F2F study and team meetings (venue, cost, agenda, etc), support team teleconferences, assist with staff onboarding as required by country/region
Depending on the country/region, the CSA may provide varying levels of COM support to the department rather than to assigned studies as needed.
You will need to have:
Bachelor's Degree in a related discipline, preferably life science.
Proficiency with MS Office Suite (excel, word, powerpoint)
Understanding of the drug development process either via education or experience in the life sciences field.
Preferably minimum experience of 3 year in Development
Excellent collaboration and interpersonal skills, unafraid to ask questions.
Strong organizational skills and ability to manage competing priorities.
Strong attention to detail
Effective written and verbal communication skills
We would prefer for you to have:
Prior experience working in clinical research
Medical knowledge and ability to learn relevant Alexion rare disease areas.
Ability to work in an environment of remote collaboratorsand in amatrix reporting structure
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.
Ability to look for and champion more efficient and effective methods/ processes of delivering quality clinical trials with reduced budget and in less time.
Team oriented and flexible; ability to respond quicky to shifting demands and opportunities
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.
The annual base pay for this position ranges from $ 74,223 to $111,335. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
