Senior Specialist, Global Trial
Posted on: 26 Feb 2021
Princeton, NJ
Job Description
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Responsibilities
Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:
Study/Project Planning, Conduct and Management
* Understands study level tools and plans.
* Provides support to the GTM along with the appropriate teams for response to country/regulatory and IRB/IEC.
* Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies.
* Assist the GTM in driving study execution.
* Learns, observes and performs core GTS tasks and escalates appropriately.
* Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
* Raises possible issues for potential escalation to the appropriate colleagues.
* Follows instructions, determines level of understanding and seeks clarification when needed.
* Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
* Develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
* Manages global vendor site lists and resolve issues related to global site lists.
* Manages study mail-groups/distributions and SharePoint/Study Directory updates.
* Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
* Identifies issues and risks, develops mitigations, and escalates appropriately.
* Participates in filing activities and any associated audits as applicable.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb
New York, New York
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. The company offers drugs in oncology, immunoscience, cardiovascular, and fibrotic diseases. The company’s products include Opdivo, a biological product for anti-cancer indications; Eliquis, an oral inhibitor targeted at stroke prevention in adult patients with non-valvular atrial fibrillation, and the prevention and treatment of venous thromboembolic disorders; and Orencia, a biological product for adult patients with moderately to severely active RA and prostate-specific antigen, as well as reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
It also provides Sprycel, a tyrosine kinase inhibitor for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; and Baraclude, an oral antiviral agent for the treatment of chronic hepatitis B. In addition, the company offers Reyataz, a protease inhibitor for the treatment of human immunodeficiency virus (HIV) and Evotaz; Sustiva franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV; and Daklinza NS5A replication complex inhibitor, Sunvepra NS3 protease inhibitor, and Beclabuvir NS5B inhibitor. It sells products to wholesalers, retail pharmacies, hospitals, government entities, and medical profession. It has collaboration agreements with Nektar Therapeutics; Janssen Pharmaceuticals, Inc.; Biocartis Group NV.; and FameWave Ltd.
The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.
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IndustryBiopharmaceuticals
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No. of Employees23, 300
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Website
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Jobs Posted1641
