Local Study Associate Director - One Sponsor (Denmark)
TFS, Denmark
Job Description
TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Local/Regional Study Manager/Associate Director who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS HealthScience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
TFS HealthScience is looking for a Regional Study Manager/Associate Director to be home based in Denmark. This opportunity is permanent with career progression focus and will be one sponsor dedicated to one of our extraordinary pharmaceutical clients. We look forward to receiving your application!
Responsibilities:
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
- Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
- Ensures 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 SOPs.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
- Reports study progress/update to the Global Study Leader/ Global Study Team including SMM Lead.
- Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
- Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
- Participates in training and coaching new members of the Local Study Team ensuring compliance with