|Location||Anywhere, United States of America|
|Date Posted||April 13, 2021|
|Job Level||Manager or Senior Manager|
|Other Locations||United States|
Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures.
Xcenda, a business unit of AmerisourceBergen Corporation, is an integrated, world-class health care consulting organization focused on value, reimbursement and patient access. For more than 2 decades, Xcenda has helped global biopharmaceutical companies as well as emerging early-phase firms successfully commercialize innovative medical treatments and technologies in complex and cost-constrained global markets. Our broad, yet strategically connected, array of consulting services supports all phases of the product lifecycle. Our experts provide customized solutions and innovative approaches that discover and communicate the value of pharmaceuticals and other healthcare technologies.
As a member of the Xcenda 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 difference. Whether you join us in one of our core locations: Tampa, Charlotte, San Francisco or Washington D.C. – or work remotely like many of our Associates, you will experience what we call "Commitment that Counts" – a mindset and attitude we all share. It is the commitment that we have to our clients, to each other, and to the patients we serve that makes Xcenda such a special and unique organization and more than just a place to work. We are a group of highly motivated people -- all dedicated experts in what we do --- who value accountability, collaboration, customer focus, innovation, integrity, and passion. We 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 excellence. Play a vital role in helping patients gain access to life-saving therapies. Take the next step today and learn how you can join us.
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, level and responsibility of role may vary.
- 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
- Work independently and proactively
- Strong organizational skills
- Detail oriented
- Strong work ethic
- Positive attitude
- Functions as a team player
- Works efficiently on all tasks within the allotted number of hours by deadline
- Excellent verbal and written communication skills
- Ability to manage a diverse project load
- Produce positive results in a high-pressure environment
- Prioritize tasks and complete assignments in a thorough and competent manner
- Recognize areas to increase efficiency and contribute solutions
- Healthcare for associates and eligible dependents, same-sex and domestic partners
- Paid time off, including vacations and holidays
- Paid volunteer time off
- Life insurance and disability protection
- Pet insurance
- Employee Stock Purchase Program
- Retirement benefits and more…
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.
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This is a remote role for candidates located in the United States.