Global Trial Specialist
Posted on: 24 Jan 2021
Summit, 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.
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.
Celgene
Summit, NJ
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.
The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.
The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.
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IndustryBiopharmaceuticals
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No. of Employees8, 852
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Website
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Jobs Posted1399
