Sr Medical Project Coord

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:
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 line
listings 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 services
when SAE case processing has not been contracted. Manages project
implementation 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 forecasting
actual 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 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 andoffers 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 (Physicians Assistant) or licensed RN
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years) to include 5 years clinical safety experience (clinical research monitoring orpharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

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

Management Role:
No management responsibility

Working Conditions and Environment:
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.