Study Start-Up Manager

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Oversee and implement study start-up tasks in accordance with client protocols, ICH-GCP standards, and local regulations.

• Prepare, review, monitor, and manage site regulatory documents at both the country and site levels.

• Ensure prompt collection and uploading of essential documents into the eTMF (electronic Trial Master File) following ICH-GCP guidelines.

• Collaborate with regulatory authorities and IEC/IRB for the submission of applications and necessary documentation during the start-up phase.

• Maintain, assess, and report on site performance metrics and study advancement.

• Update the CTMS (Clinical Trial Management System) and other systems with data from study sites according to required deadlines.

• Follow up on unresolved actions with study sites to guarantee timely resolution.

• Work closely with CRAs and Local Study Teams to ensure compliance with regulatory and documentation requirements.

• Assist in quality control checks to ensure that all essential documents are collected and validated before site activation.

• Contribute to the clinical and operational feasibility evaluations of potential studies.

• Actively participate in Local Study Team meetings and provide consistent updates to line management.

• Aid in study selection processes by identifying and evaluating potential sites and investigators as necessary.

• Assume responsibility for country-level start-up activities following feasibility completion through site activation.

• Lead and manage the initial clinical trial submissions, ensuring timely preparation, coordination, and follow-up with regulatory authorities and ethics committees.

• Oversee start-up related budgets and assist in budget tracking throughout the start-up phase.

• Manage and track Import License submissions and ensure timely approvals where applicable.

• Monitor and coordinate the delivery of Investigational Product (IMP) and study equipment to ensure site readiness.

• Facilitate site activation readiness by ensuring all regulatory, contractual, and logistical prerequisites are fulfilled.

• Proactively identify and mitigate risks or delays that could impact study start-up timelines.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field.

• Strong knowledge of ICH-GCP and applicable local regulations.

• Demonstrated experience in clinical trial start-up activities at the country level, with comprehensive involvement from feasibility completion to site activation.

• Basic understanding of the drug development process.

• Excellent grasp of Clinical Study Management and study start-up procedures.

• Significant hands-on experience in preparing, coordinating, and managing initial regulatory submissions.

• Proven ability to take ownership of start-up timelines, with the capacity to track, manage, and drive site activation milestones.

• Proven capability to identify start-up risks, manage competing priorities, and develop solutions to ensure timelines are adhered to.

• Experience in supporting or overseeing study start-up budgets and financial aspects related to activation.

• Good understanding of the local regulatory landscape and Ministry of Health procedures.

• Solid knowledge of Import License processes and regulatory requirements pertinent to clinical trials.

• Experience in coordinating the delivery of Investigational Product (IMP) and study equipment to sites.

• Strong knowledge of essential documents and the ability to ensure site readiness, including ISF preparation and inspection readiness.

• Good collaboration and interpersonal abilities.

• Fluency in Turkish and English (both written and spoken).

• Exceptional attention to detail and accuracy.

• Strong verbal and written communication skills.

• Ability to learn and adapt to IT systems.

• Excellent organizational and time management skills.

🏝️ Benefits

• Opportunity to engage in diverse, high-impact clinical trials across various therapeutic areas.

• Collaborative and supportive work environment with experienced clinical professionals.

• Professional development and training opportunities available.

• Competitive compensation and benefits package offered.

• Flexible work arrangements to accommodate personal needs.

• Opportunities for career advancement within a global organization.