Job details
Job type full-time
Full job description
Are you looking to make a difference in a patient’s life? at amerisourcebergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a differenceAs an organization, we are united in our responsibility to create healthier futuresJoin us and apply today!
What you will be doing
As a member of the amerisourcebergen team, you will be working, learning, and teaching alongside intelligent, collaborative, and experienced professionals who are inspired by what they do and highly motivated to make a differenceIt is the commitment that we have to our clients, to each other, and to the patients we serve that makes amerisourcebergen such a special and unique organization and more than just a place to workWe are a group of highly motivated people - all dedicated experts in what we do - who value accountability, collaboration, customer focus, innovation, integrity, and passionWe believe life is meant to be pursued and enjoyed through creative thinking, ethics and bringing an entrepreneurial spirit to everything we do.
Share in our commitment to excellencePlay a vital role in helping patients gain access to life-saving therapiesTake the next step today and learn how you can join us.
The manager, clinical research is responsible for clinical operational planning activities and leading study execution in accordance with ich good clinical practices, fda guidelines, local regulations and xcenda standard operating procedures.
Primary duties and responsibilities:
The responsibilities of the position may include, but are not limited to, the following:
Develops and/or reviews protocols and clinical study reports
Designs and/or review icf templates, crfs, procedure manuals, and other project-specific documents
Reviews study budgets and timelines
Identifies clinical sites and conducts feasibility assessments
Manages study sites from start-up through close-out
Conducts qualification, initiation, interim and close out monitoring visits and prepares visit reports
Designs and reviews icf templates, crfs, procedure manuals, and other project-specific documents
Performs testing for electronic data capture (edc) system.
Monitors study data to ensure accuracy and integrity; generates and resolves data queries
Creates and maintains the trial master file (tmf); ensures that regulatory documents are acquired, complete, and compliant
Coordinates irb submissions, amendments and annual updates
Tracks and ensures patient enrollment targets are achieved
Verifies appropriate reporting and documentation of adverse events and protocol deviations per protocol and sponsor requirements
Ensures overall study adherence to the protocol and applicable regulations and sops
Assists in the preparation of proposals in response to rfps received from clients
Other duties as assigned
Depending on experience, the level and responsibility of role may vary.
This role is a remote role for candidates located anywhere in the united states.
#remote
What your background should look like
Experience and educational requirements:
Bachelor’s degree in life-sciences or related field
Minimum of 3 years clinical research experience in the pharmaceutical or medical device industry
Strong working knowledge of gcps and federal regulations
High level of organization and self-motivated to manage multiples sites and projects simultaneously
Previous experience with electronic data capture systems is preferred
Proficiency in ms word, ms excel, ms powerpoint
Excellent written and oral communication skills
Minimum skills, knowledge and ability requirements:
Possesses and applies a broad knowledge of principles, practices, and procedures of particular field of specialization to the completion of difficult assignments
Broad technical knowledge of outcomes research and health economics
Structured and well organized
Excellent writing skills as well as the ability to communicate complex material in presentations and discussions in a straightforward manner
Ability to work well in a dynamic, successful consulting firm, which maintains high quality standards and demands excellence
Database management and analytical and statistical skills
Economic modeling skills
Medical writing skills
Experience developing outcomes research/health economics study protocols
Proficiency in microsoft office suite
Strong clinical skills preferred
Strong work ethic
What amerisourcebergen offers
We offer competitive total rewards compensationOur commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offerMany benefits are company-paid, while others are available through associate contributionsSpecific benefit offerings may vary by location, position and/or business unit.
Schedule
Full time
Equal employment opportunity
Amerisourcebergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
