Manager, GMA Oncology- Clinical Trial Management & Resources in Basking Ridge, New Jersey at DSI

Date Posted: 2/17/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Provide support for all aspects of Global Clinical Operations with high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines (i.e. Company Initiated Studies (CIS), Expanded Access Programs (EAP), Real World Evidence (RWE) programs, Investigator Initiated studies (IIS)). Facilitate successful execution, and adherence to timelines and clinical milestones of Oncology Medical Affairs activities as appropriate.

Responsibilities:

Clinical Operations Study/ Program Management
Company Initiated studies (CIS). Real World Evidence Studies, Expanded Access Programs

Support the preparation and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines
Review protocols to ensure designs are implementable to efficiently achieve the objectives.
Support the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable.
Support activities to drive adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.

Investigator Initiated Studies (IIS)

Support the oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS as per the Standard Operating Procedure (SOP)(regional review, Global review, tracking of milestones as per contract)
Ensure the IIS system for management of IIS review and approvals (IMPACT) is current and accurate

Vendor/CRO/Supplier Management
Support and facilitate the creation of bid templates for the selection of vendors/ suppliers CROs
Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level
Identify and evaluate potential clinical partners which may include CROs, investigators, and other vendors necessary to execute the medical program.
Support the selection of experienced CRO; and internal resources for proper oversight and management internally

Regional Support
Work with the Regional Teams and key stakeholders to drive alignment on key activities and expectations
Ensure regular updates provided to Sr Director on trial metrics and data
Establish strong partnership with Regional Operational managers to drive operational excellence in regions and countries for medical affairs clinical activities.

Process/Policies
Provide input to process standards and tools to achieve excellence in trial operations and management.
Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

  • Bachelors degree or equivalent education/experience in life science/healthcare required
  • ≥ 3+ yrs w/M.S., 5+ years w/B.S. of relevant experience in pharmaceutical clinical research experience preferred.
  • Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
  • Mindset of putting the patient first, as well as have a values-driven leadership style where integrity drive all behaviors, decisions, and actions
  • Working knowledge of clinical development process, regulatory requirements and GCP.
  • Must be highly organized and detail-oriented

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.