Work Schedule

Environmental Conditions

Job Description

*5000 JOINING BONUS AVAILABLE FOR STARTERS BEFORE APRIL 2025*

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of lifechanging therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Our Clinical Operations colleagues within our PPD clinical research services provide endtoend support for clinical trials from study start up to monitoring through to study close out across commercial and government contracts. Together we help clients define and develop clinical programs minimize delays and execute highquality costefficient clinical studies.

Position Overview:

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or onsite visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO FSP Government etc.. Acts as a site processes specialist ensuring that the trial is conducted according to the approved protocol ICHGCP guidelines applicable regulations and SOPs to guarantee subjects rights wellbeing and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Duties and Responsibilities:

• Monitors investigator sites with a riskbased monitoring approach: applies root cause analysis (RCA) critical thinking and problemsolving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR SDV and CRF review as applicable through onsite and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and followup on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place according to ICHGCP and applicable regulations. Conducts onsite file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites client company and internal project teams through written oral and/or electronic contacts. Responds to company client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement as required.

Education:

• Bachelors degree in a life sciences field.
• At least 6 months of experience of independent onsite monitoring in a Pharmaceutical or Clinical Research Organisation.
• Experience in clinical trials medical terminology medical research clinical research health care or in a health sciences field.
• Valid drivers license where applicable.

Knowledge Skills & Abilities:

• Oncology or Haematooncology experience highly preferable.
• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
• Good oral and written communication skills with ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilization of good listening skills attention to detail and the ability to perceive customers underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Welldeveloped critical thinking skills including but not limited to: critical mindset indepth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good digital literacy: proven knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.

Why join us

We hire the best develop ourselves and each other and recognize the power of being one team! We understand that you will want to grow both professionally and personally throughout your career and therefore at you will benefit from an awardwinning learning and development programme ensuring you reach your potential.

What we Offer:

As well as being rewarded a competitive salary we have an extensive benefits package based around the health and wellbeing of our employees. We have a flexible working culture where we truly value a worklife balance. Weve grown sustainably year on year but continue to offer a collaborative environment with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other nondisability related technical issues will not receive a response.