Manager, GMA Oncology, Clinical Trial Management & Resources

Location
Basking Ridge, NJ, United States
Posted
Apr 24, 2021
Ref
10860BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

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:

Operational Support
Manage company sponsored review committees for interventional and non-interventional studies (including those that are part of an alliance and/or other functions), by creating templates, agendas, taking meeting minutes, scheduling, coordinating reviews, assisting in developing charters, and more as applicable.

Support the team by managing all systems (i.e., CTMS, safety portal, etc.); this includes inputting data in a timely manner, running reports, and assisting in the development of new systems.

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.

Reporting metrics and KPIs.

Manage clinical operations email mailboxes, as applicable, and triaging as appropriate.

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 and Line Function Support
Work with the Regional and Functional Teams and key stakeholders to drive alignment on key activities and expectations

Ensure regular updates provided to Associate Director on trial metrics and data

Establish strong partnership with Regional and Functional Teams 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

Support new clinical operations technology solutions, including assessment and implementation

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.

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 is current and accurate

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

Education/Experience:
  • A minimum of an Associate's Degree is required; Bachelor's Degree or higher level degree preferred.
  • ≥ 3+ years w/M.S., 5+ years w/B.S., 10+ years w/Associates of relevant experience in pharmaceutical clinical research or healthcare experience required.
  • 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.
Job Title
Manager, GMA Oncology, Clinical Trial Management & Resources

City
Basking Ridge

Functional Area
Global Oncology Medical Affairs

State
New Jersey