Medical Project Coordinator, EMEA Operations

4 tygodni temu

Poland MyGwork Pełny etat
Job Summary

This role is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork – the largest global platform for the LGBTQ+ business community.

Please note that direct contact with the recruiter should be avoided.

Job Description

Summarized Purpose: Manage and coordinate medical projects for one or more programs in collaboration with management and other partners to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle.

Essential Functions: Independently review safety data, utilizing line listings, company dashboards 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.

Summarize safety data for review meetings.

Review designated sections of aggregate reports.

Function independently 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 plans 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.

Monitor project financial status, unit forecasting, actual realization, and team allocations in systems.

Coordinate staff projections based on contract values and actual hours used.

Raise financial and/or operational risks and attend risk management meetings to discuss.

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 offer solutions.

May assist management in training and mentoring.

Present at business development, client, and investigator meetings and participate in strategy/business development calls.

Represent studies at risk management meetings.

Qualifications:

Education and Experience: Bachelor's degree in Nursing or related Health Sciences (Physician's 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.

Solid understanding 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.

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