Study Start-Up Manager

Parexel

Study Start-Up Manager overseeing clinical trial start-up activities at Parexel. Ensure compliance with ICH-GCP guidelines and local regulations while collaborating with clinical teams.

Posted 6/23/2026full-timeRemote • 🇹🇷 TurkeyMid-LevelSeniorWebsite

ATS Keywords

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Hard Skills

clinical trial start-upregulatory submissionsstudy managementsite activationbudget trackingImport License processesessential documents managementfeasibility assessmentsICH-GCPdrug development process

Soft Skills

collaborationinterpersonal skillsattention to detailverbal communicationwritten communicationorganizational skillstime managementproblem-solvingadaptabilityownership

Tools & Technologies

eTMFCTMSregulatory documentation systemsclinical trial management systemsstudy tracking toolsdata management systemsbudget management toolscommunication platformsproject management softwareregulatory compliance tools

Industry Keywords

clinical trialsregulatory authoritieslocal regulationsMinistry of Health proceduresInvestigational Product (IMP)site readinessstudy performance metricsstudy progressethical committeeslocal study teams

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage and conduct study start-up activities in compliance with client procedures, ICH-GCP guidelines, and local regulations
Prepare, review, track, and manage site regulatory documentation at country and site levels
Ensure timely collection and uploading of essential documents into the eTMF (electronic Trial Master File) in accordance with ICH-GCP standards
Coordinate with regulatory authorities and IEC/IRB for submission of applications and required documentation during the start-up period
Maintain, review, and report on site performance metrics and study progress
Update CTMS (Clinical Trial Management System) and other systems with data from study sites according to required timelines
Follow up on outstanding actions with study sites to ensure timely resolution
Collaborate closely with CRAs and Local Study Teams to ensure regulatory and documentation compliance
Support quality control checks to verify that all essential documents are collected and verified prior to site activation
Contribute to clinical and operational feasibility assessments of potential studies
Participate actively in Local Study Team meetings and provide regular updates to line management
Support study selection processes by identifying and assessing potential sites and investigators (as needed)
Take ownership of country-level start-up activities after feasibility completion through site activation
Lead and manage initial clinical trial submissions, ensuring timely preparation, coordination, and follow-up with regulatory authorities and ethics committees
Oversee start-up related budgets and support budget tracking during the start-up phase
Manage and track Import License submissions and ensure timely approvals where applicable
Monitor and coordinate Investigational Product (IMP) and study equipment delivery to ensure site readiness
Drive site activation readiness by ensuring all regulatory, contractual, and logistical requirements are completed
Proactively identify and mitigate risks or delays impacting study start-up timelines.

Requirements

What you’ll need

Bachelor's degree in life science or a related discipline
Good knowledge of ICH-GCP and relevant local regulations
Proven experience in clinical trial start-up activities at country level, with end-to-end involvement from feasibility completion through site activation
Basic understanding of the drug development process
Excellent understanding of Clinical Study Management and study start-up procedures
Strong hands-on experience in preparing, coordinating, and managing initial regulatory submissions
Demonstrated ownership of start-up timelines, with the ability to track, manage, and drive site activation milestones
Proven ability to identify start-up risks, manage competing priorities, and implement solutions to ensure timelines are met
Experience supporting or overseeing study start-up budgets and financial aspects related to activation
Good understanding of local regulatory environment and Ministry of Health procedures
Solid understanding of Import License processes and regulatory requirements relevant to clinical trials
Experience coordinating Investigational Product (IMP) and study equipment delivery to sites
Strong knowledge of essential documents and ability to ensure site readiness, including ISF preparation and inspection readiness
Good collaboration and interpersonal skills
Fluency in Turkish and English (written and spoken)
Excellent attention to detail and accuracy
Good verbal and written communication skills
Ability to learn and adapt to IT systems
Strong organizational and time management skills.

Benefits

Comp & perks

Opportunity to work on diverse, high-impact clinical trials across multiple therapeutic areas
Collaborative and supportive work environment with experienced clinical professionals
Professional development and training opportunities
Competitive compensation and benefits package
Flexible work arrangements
Career growth opportunities within a global organization.