Senior Medical Project Coordinator

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Medical Project Coordinator

At Thermo Fisher Scientific youll do meaningful work that makes a positive impact on global health. Youll be part of a global organization supporting leading pharmaceutical and biotechnology companies while contributing to the development of life-changing therapies. Through collaboration innovation and continuous learning youll have the opportunity to grow your career while helping advance clinical research worldwide.

What Youll Do:
The Senior Medical Project Coordinator manages coordinates and evaluates 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 develops collaborative relationships with client company personnel.

Work independently to perform 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 summations for safety review meetings.
Review designated sections of aggregate reports.
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 medical management plan(s) on studies (as applicable)
and ensure that the processes included in the plan document are reflective of
the contract and services requested for studies that have department
involvement and those that are 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.
Independently determine hours required for out of scope work for the teams
and provide this to the finance/study team for contract modifications. Attend
meetings to discuss/justify the modification requirements.
Resolve complex problems through in-depth evaluation of various factors and
offers solutions. May assist management in training and mentoring.
Present at business development client and investigator meetings and
participates in strategy/business development calls. Represent studies at risk
management meetings.

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
5 years) to include 5 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:
Advanced knowledge of GCPs for medical oversight of clinical trials
Knowledge of drug development and safety reporting
Advanced knowledge of safety data trending to include coding
Working knowledge of biostatistics data management and clinical procedures
Excellent problem solving and critical thinking skills
Excellent project management and budget skills
Effective mentoring skills and ability to train and lead others
Strong oral and written communication skills
Strong attention to detail
Ability 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. Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations frequent travels both domestic and international.

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.