Sr Medical Project Coord

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
11 Jul 2019
Closes
10 Aug 2019
Ref
1157200
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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.

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. Creates and maintains safety and 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. Works independently to monitor the project financial status, unit forecasting, actual realization, and team allocation updates in systems. Coordinates staff projections based on contract values and actual hours used and assists with contract modification questions. Presents at business development, client, and investigator meetings and participates in strategy/business development calls. Represents studies at risk management meetings.
Resolves complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring.

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)
Knowledge, Skills and Abilities:
    Advanced knowledge of GCPs for medical oversight of clinical trials and SAE processing 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 Strong problem solving and critical thinking skills Strong 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


*LI-EP1

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