Senior clinical trial management associate
TALENTRUPT RPO LLP
Remote
Job description

Title : Senior clinical trial management associate
Pay rate : $38/hr.-40/hr.
Remote (100%)
12+ months (with full possibility of extension / temp to perm on the study needs and performance based)

Oncology is a key therapeutic area for our client, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. Our Client is expanding its oncology early development pipeline. More than 1,000 scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is located in either in North Chicago, IL or
Redwood City, CA.

In Oncology Early Development, the Sr Clinical Trial Management Associate is responsible for supporting the planning and execution of one or more early phase oncology clinical research studies. The SMA performs clinical trial related responsibilities and CRO/vendor oversight activities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.

Responsibilities:

  • Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
  • Supports the Study Project Manager in leading the cross functional study team:

o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date

  • Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
  • Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
  • Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
  • Proactively identify and resolve and/or escalate study related issues
  • Participates in process improvement initiatives

Qualifications:

  • Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
  • Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
  • Experience working in oncology and/or working with CRO preferred.
  • Possesses good communication skills.
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
  • Preferred exposure to study initiation through study completion.

Job Type: Contract

Salary: $35.00 - $38.00 per hour

Schedule:

  • 8 hour shift
  • Monday to Friday

Work Location: Remote

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