Medical Project Cordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Lead Medical Project Coordinator

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 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.


The Lead Medical Project Coordinator leads the management coordination and evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency alignment and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and proactively liaises with clients to ensure optimal performance and utilization of medical project team(s).

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

What Youll Do:
Work independently to perform and/or lead first pass review of safety data
utilizing line listings company dashboard(s) and/or other visualization tools.
Review data for safety trends coding consistencies and potential follow up
with investigator sites. Proactively identify any potential issues and resolve or
escalate as appropriate.
Review safety data and provide comprehensive summations for safety review
meetings. Review designated sections of aggregate reports.
Initiate and lead initiatives to improve current processes and develops new
processes regarding medical monitoring and department services. May develop
guidance documents and assist with the implementation and/or revision of
corporate level documents such as SOPs and WPDs.
Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation coordination maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
Create and maintain safety and medical management plan(s) on studies (as
applicable) and ensure that the processes included in the plan document are
reflective of the contract and service requested for studies that have
department involvement as well as standalone studies (ex. MM and/or MPC).
Work independently to monitor the project financial status unit forecasting
actual realization and team allocations in systems. Coordinate staff
projections based on contract values and actual hours used. Escalate any
financial and/or operational risks and can attend risk management meetings to
discuss.
Present at business development client and investigator meetings and
participate in strategy/business development calls. Represent studies at risk
management meetings.
Independently determine hours required for out of scope work for both the MM
and MPC and provides this to the finance/study team for contract modifications.
Attend meetings to discuss/justify the modification requirements.
Train and develop new team members. Serve as main point of contact for
team member questions with escalation to management as appropriate. May
provide input on individual performance to direct line manager. Organize and
lead meetings with team members to discuss potential process issues answer
questions and brainstorm ideas and solutions.
Resolve complex problems through in-depth evaluation of various factors and
offers solutions.

Education and Experience Requirements:
Bachelors degree in Nursing or related Health Sciences (Physicians Assistant) or licensed RN
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years) to include 8 years clinical safety experience (clinical research monitoring or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

In some cases an equivalency consisting of a combination of appropriate education training
and/or directly related experience will be considered sufficient for an individual to meet the
requirements of the role.

Knowledge Skills Abilities:
Superior knowledge of GCPs for medical oversight of clinical trials
Advanced knowledge of drug development and safety reporting
Extensive knowledge of safety data trending to include coding
Good knowledge of biostatistics data management and clinical procedures
Exceptional problem solving and critical thinking skills
Exceptional project management and budget skills
Excellent mentoring skills and ability to train and lead others
Exceptional oral and written communication skills
Detail-oriented mindset
Able to work in a collaborative team environment
Ability to maintain a positive and professional demeanor in challenging circumstances

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:

Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves

Why join us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.