Senior Medical Project Coordinator, EMEA
Senior Medical Project Coordinator, EMEA
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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.
Manages coordinates and evaluates medical projects for one or more programs in collaboration withmanagement and other stakeholders to ensure consistency alignment and compliance of internalprocesses as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with clientcompany personnel.
Essential Functions:
- Works independently to perform first pass review of safety data utilizing linelistings company dashboard(s) and/or other visualization tools. Reviews data forsafety trends coding consistencies and potential follow up with investigatorsites. Proactively identifies any potential issues and resolves or escalates asappropriate.
- Reviews safety data and provides summations for safety review meetings.
- Reviews designated sections of aggregate reports.
- Independently functions as the Project Lead for medical monitoring serviceswhen SAE case processing has not been contracted. Manages projectimplementation coordination maintenance and close out of assigned studies asapplicable. Serves as the primary point of contact for clinical project teams onstudies and can act as the alliance level lead on larger alliance/multi-protocolstudies.
- Creates and maintains medical management plan(s) on studies (as applicable)and ensures that the processes included in the plan document are reflective ofthe contract and services requested for studies that have departmentinvolvement and those that are standalone studies (ex. MM and/or MPC).
- Works independently to monitor the project financial status unit forecastingactual realization and team allocations in systems. Coordinates staff projectionsbased on contract values and actual hours used. Escalates any financial and/oroperational risks and can attend risk management meetings to discuss.
- Independently determines hours required for out of scope work for the teamsand provides this to the finance/study team for contract modifications. Attendsmeetings to discuss/justify the modification requirements.
- Resolves complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring.
- Presents at business development client and investigator meetings andparticipates in strategy/business development calls. Represents studies at riskmanagement meetings.
Qualifications:
Education and Experience:
- 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 and 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
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.
Required Experience:
Senior IC
Employment Type
Full-Time
