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Manager gma oncology clinical trial management & resources

Daiichi Sankyo

This is a Full-time position in Basking Ridge, AZ posted May 22, 2019.

The Manager, GMA Oncology-Clinical Trial Management & Resources will 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: Qualified candidates must have a Bachelor’s degree from an accredited college or university; Bachelor’s degree or equivalent education/experience in life science/healthcare required 3+ years with M.S., 5+ years with 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 Fluent English (oral and written) Ability to travel up to 15% 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 Medical Affairs Oncology State New Jersey