Job summaryperforms assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.responsible for delivery with oversight from line manager in areas such as investigator site contracts, ethics and regulatory submissions, collection and review of essential documents for site initiation and activation.ensures local activities align with agreed timelines, budgets, and quality standards, and ensures efficient start-up process on assigned studies.job responsibilitiesact as main contact with regulatory authorities (ra) and central/regional ethics committees under supervision of project lead or site activation manager.accountable to project lead/site activation manager and line manager for deliverables at the project level.provide quality on deliverables at the country level, follow project requirements and applicable country rules with oversight from ssu country manager.work within forecasted submission/approval timelines, track milestone progress in ssu tracking system, provide rationale for delays, assist contingency plan, and escalates issues.monitor basic financial aspects of the project and hours/tasks per contract, escalating discrepancies timely.review and comply with standard operating procedures (sops) and work instructions (wis), keep training records updated, and ensure timesheet compliance.ensure all relevant documents are submitted to the trial master file (tmf) per company sop/sponsor requirements.local submissions specialist: follows project direction from csa and sam, prepares and submits central ec, local ec, ra applications, and other local regulatory submissions, handles ongoing submissions and notifications, includes safety notifications as required by local rules.oversee site activation end-to-end process at the country/site level, providing support with site selection lead and pm/sam to ensure appropriate sites are selected for individual studies.local investigator contract and budget negotiator: support sam to agree on country template contract and budget, produce site-specific contracts, assist negotiations of budget and contract with site, and ensure quality control.qualificationsassociate's degree or equivalent combination of education and training.good understanding of clinical trial process across phases ii-iv and ich gcp.ability to interact effectively and appropriately with investigative site personnel.good organizational skills, attention to detail, and proven ability to handle multiple tasks effectively.ability to take direction from multiple individuals and set priorities accordingly.ability to communicate across multiple function groups (clinical team, pm, director).
demonstrated ability to work independently, as well as part of a team.utilized problem‐solving techniques effectively.quality‐driven in all managed activities.flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.strong computer skills, including word, excel, powerpoint, publisher.eeo statementinformationtasks, duties, and responsibilities as listed in this job description are not exhaustive.the company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the job description.the company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.further, nothing contained herein should be construed to create an employment contract.occasionally, required skills/experiences for jobs are expressed in brief terms.any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the eu equality directive, in relation to the recruitment and employment of its employees.the company is committed to compliance with the americans with disabilities act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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