Local Study Associate Director - Sponsor Dedicated (m/w/d)

Job Title: Local Study Associate Director - Sponsor Dedicated (m/w/d)

Job Location: Budapest, Hungary

Job Location Type: Home-based

Job Contract Type: Full time

Job Seniority Level:

To reputed company Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as reputed company as relevant local regulations. In reputed company to leading LST(s), the Local Study Associate Director (LSAD) may reputed company site monitoring as needed to support the flexible reputed company model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, reputed company and documentation archived.

Responsabilities:

• Has the overall responsibility for the study commitments reputed company the country and for reputed company delivery of data to required reputed company.
• 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 Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest reputed company.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site reputed company Risk Assessment, and conducting Site Qualification reputed company to evaluate suitability and reputed company risks.
• Ensures reputed company submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure reputed company delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures reputed company preparation of reputed company Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures reputed company preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures reputed company preparation of country level Master Informed Consent reputed company (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.
• Ensures reputed company 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 reputed company to enrol, and in line with Sponsor 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 reputed company 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.
• Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-reputed company advices the monitor(s) on study reputed company reputed company.
• Performs any required co-monitoring, Accompanied Site reputed company/training reputed company with study CRAs.
• Proactively identifies risks and facilitates reputed company of reputed company study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven reputed company.
• reputed company works towards achieving good personal relationships with reputed company Local Study Team members, sites’ staff and global stakeholders.
• Reports study reputed company/update to the Global Study Associate Director/ Global Study Team including SMM reputed company.
• Contributes to patient recruitment reputed company 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 reputed company identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National reputed company Investigator on recruitment and other study reputed company, if applicable.
• Plans and leads National Investigator meet Ensures that reputed company study documents are reputed company for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in reputed company with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level reputed company with local policies and reputed company of ethics.
• Provides feedback on any research reputed company information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with Sponsor´s reputed company of Ethics, company policies and procedures relating to people, finance, technology, reputed company and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Requirements:

• Bachelor degree in reputed company discipline, preferably in life science, or equivalent qualification (*).
• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other reputed company fields (Medical Affairs-led or reputed company-led studies).
• Good knowledge of international guidelines ICH GCP as reputed company as relevant local regulations.
• Proven ability to reputed company and motivate cross functional teams to deliver clinical trials according to or reputed company of time plan, budget and with required reputed company.
• Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• reputed company good understanding of the Study Drug Handling Process and the Data Management Process.
• Excellent project management skills.
• Excellent team building and interpersonal skills, organizational reputed company and verbal and written communication skills
• Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
• Excellent knowledge of spoken and written English and local languages.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required

"Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based reputed company of these locations will not be considered”.

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

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Originally posted on Himalayas

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