Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description
Summarized Purpose: Manages, coordinates and evaluates 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. Represents the company in the medical research community and develops collaborative relationships with client company personnel.
Essential Functions:
Works independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identifies any potential issues and resolves or escalates as appropriate.
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 services when SAE case processing has not been contracted. Manages project implementation, coordination, maintenance and close out of assigned studies as applicable. Serves 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.
Creates and maintains medical management plan(s) on studies (as applicable) and ensures 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).
Works independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinates staff projections based on contract values and actual hours used. Raises any financial and/or operational risks and can attend risk management meetings to discuss.
Independently determines hours required for out of scope work for the teams and provides this to the finance/study team for contract modifications. Attends meetings 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 and participates in strategy/business development calls. Represents studies at risk management meetings
Qualifications:
Education and Experience:
Bachelors 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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