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About the Role

Thermo Fisher Scientific is seeking individuals to join their mission of making the world healthier, cleaner, and safer by enabling customers through research, development, and delivery of life-changing therapies. The clinical department defines, develops, and delivers clinical programs, with global Clinical Operations colleagues providing end-to-end support for clinical trials. This role involves performing and coordinating clinical monitoring and site management, ensuring protocol and regulatory compliance, and developing collaborative relationships with investigational sites.

Responsibilities

Performs and coordinates all aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Acts as a site processes specialist, ensuring trial conduct aligns with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
Ensures subjects' rights, well-being, and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Monitors investigator sites using a risk-based monitoring approach.
Applies root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring.
Assesses investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner.
Communicates observed deficiencies and issues to clinical management and follows them through to resolution.
Maintains regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process.
Ensures shared responsibility with project team members for issue/finding resolution.
Investigates and follows up on findings.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS).
Performs QC checks of reports generated from the CTMS system.
Participates in investigator meetings.
Identifies potential investigators in collaboration with the client company.
Initiates clinical trial sites according to relevant procedures.
Ensures trial close out and retrieval of trial materials.
Ensures required essential documents are complete and in place.
Conducts on-site file reviews as per project specifications.
Assists in the preparation of project publications/tools and shares ideas/suggestions with team members.
Performs additional study tasks as assigned by CTM.
Facilitates effective communication between investigative sites, the client company, and the PPD project team.
Responds to company, client, and applicable regulatory requirements/audits/inspections.
Maintains and completes administrative tasks such as expense reports and timesheets.
Contributes to other project work and initiatives for process improvement.

Requirements

Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification.
Previous experience in a clinical environment with exposure to clinical research, healthcare, or clinical trials.
Valid driver's license.
Full Right to work in Germany.
Fluency in English and German language to at least C1 level.

Skills

Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills
Ability to handle Risk Based Monitoring concepts and processes
Effective oral and written communication skills
Ability to maintain customer focus
Effective social skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable
Ability to work in a team or independently
Good computer skills: proficient knowledge of Microsoft Office and ability to learn appropriate software
Good presentation skills

Location

Home-based
Munich
Karlsruhe

Work Type

Permanent
Full-time (1 FTE)
Part-time (0.8 FTE / 80%)
Office-based
Hybrid
Remote

Experience Level

Previous experience in a clinical environment with exposure to clinical research, healthcare or clinical trials

Education Level

Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification

About the Company

Thermo Fisher Scientific enables customers to make the world healthier, cleaner and safer.
The company provides teams with resources for career goals and advancing science through research, development, and delivery of life-changing therapies.
Their work spans laboratory, digital, and decentralized clinical trial services, with trials conducted in over 100 countries.
The PPD clinical research portfolio develops novel frameworks for clinical research.
The clinical department defines, develops, and delivers clinical programs.
Global Clinical Operations colleagues within PPD clinical research services provide end-to-end support for clinical trials, from study start-up to close-out.
They help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.

Equal Opportunity

Severely disabled applicants with the same aptitude will be given preferential treatment.
Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.