Ctm, Fsp, Emea Milano

Ctm, Fsp, Emea
Milano
Lombardia, Milano

Work Schedule

Standard (Mon-Fri)

**Environmental Conditions

Office

At Thermo Fisher Scientific, you'll 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 life-changing 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 global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end 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 high-quality, cost-efficient clinical studies.

**The PPD FSP Solution**:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions.

We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.

We deploy the same top-tier talent in ALL engagement models.

Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

**Discover Impactful Work**:

We are seeking a CTM in our FSP team that would function as a client

- embedded Unblinded Monitoring Manager.

**A day in the Life**:

- Participate in study kick off meeting

- Participate in the clinical trial team meetings with the CRO unblinded team.

- Ensure that CRO unblinded activities of the clinical trials are executed according to trial plans and in compliance with client /CRO procedures, ICH-GCP and other applicable legislations.

- Responsible for leading, guiding and overseeing the CROs unblinded activities in the assigned clinical trial.

- Provide input into training materials of the CROs concerning the unblinded trial aspects.

- Review and approve Master Site Blinding Plan

- Provide input into and/or develop trial related materials such as unblinded clinical monitoring plans, pharmacy manual and setup of IRT.

- Review unblinded monitoring visit reports and related protocol deviations to ensure reliable quality data are delivered and proactively identified and solve issues/concerns.

- Ensure that the unblinded sections and documents of the CRO's Trial Master File (TMF) are maintained and up to date.

- In collaboration with the CRO's unblinded team, ensure clinical site accountability records on site are in place, maintained and accurate.

- Communicate properly, not sharing unblinded information, with the blinded team to ensure that the blind will be maintained during the entire study.

- Provide input to the clinical development strategy/plan

- Provide input to procedures/SOPs/WIs and related documents

- Participate in workstreams

- Ensure sharing of best practices and lessons learned across trials, indications and assets.

**Knowledge, Skills & Abilities**:

- Excellent communication skills

- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial

- Experience with tools and systems for managing clinical studies (MS project, trial progress and metric systems, eCRF databases, IRT systems)

**Education & Experience**:

- Bachelor's or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc. )

or equivalent by experience

- Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors

- Experience in unblinded part of clinical studies is a plus

- Biotech experience is a plus

- Auto-immune clinical trial background is a plus

**Working Environment**:

Thermo Fisher Scientific values the health and wellbeing of our employees.

We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment/requirements for this role:

- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

- Able to work upright and stationary for typical working hours.

- Ability to use and learn standard office equipment and technology with proficiency.

- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

- May require travel.