Job Summary

Responsibilities

• Clinical Operations Study/ Program Management
  Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
  Ensure preparation and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines
  Provide strategic input into the development of the protocols to ensure designs are implementable to efficiently achieve the objectives.
  Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable.
  Develop, implement and ensure adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.
  Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, safety updates/ notifications etc
  Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership
  Have a robust management plan in place before starting a study/ program to ensure optimal control and monitoring, to minimize risks and ensure timely response to treating physicians
  Investigator Initiated Studies (IIS) and External Collaborative Research Studies (ECSR)
  Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS and External Collaborative Research Studies (ECSR) as per the Standard Operating Procedure (SOP)(regional review, Global review, tracking of milestones as per contract)
  Ensure the IIS process is revisited regularly to adhere to the (SOP) and identify and remediate/correct any gaps on a timely manner to ensure robust preparation and review by the Global IIS committee as well as proper documentation of decisions and document repository
  Oversight of the IIS system for management of IIS review and approvals (IMPACT)

• Oversight of Study Teams (ST) for GMA Medical Programs
  Develop an overarching project management plan
  Lead (or delegate to a team member) and manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance; chair ST meetings, report study progress and issues with their resolution plan; lead trial level interactions with relevant functions including Drug Supply Management and local medical organizations
  Anticipate and efficiently mitigate risks

Responsibilities Continued

Collaborate with cross-functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, Regulatory Affairs, and Quality Assurance, HEOR if applicable).  Lead team to develop functional center of excellence in clinical trial execution by identifying and implementing best-in-industry practices. Accountable for overall management of clinical trial team when applicable.  Ensure clinical operations teams regulatory and Good Clinical Practice (GCP) compliance. Comply with applicable regulations, GCP and corporate policies and procedures

• Vendor/CRO/Supplier Management
  Develop clinical outsourcing specifications incorporation with respective line functions to facilitate bid templates and selection of CROs; provide strong oversight of 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.
  Ensure selection of experienced CRO; and internal resources for proper oversight and management internally
• Managerial responsibilities
  Establish annual objectives for the Clinical Operation group according to GMA priorities and individual development needs. Participate in the hiring, on-boarding, training and mentoring of new staff. Identify individual training needs to foster high levels of performance, support career development through quality development plans and proactively manage performance issues.  Manage all budgets, contracts, agreements, vendor payments related to clinical trial programs in an effective and transparent manner. Manage and report on study budgets to include addressing variances, payments and revisions, as applicable.
• Regional Support
  Work with the Regional Teams to ensure concepts and protocols are reviewed at the GMAT level with documented minutes and actions
  Ensure synopsis and protocols are reviewed at the PRG.  Liaise with the Regional Operation manager to ensure alignment on the proper infrastructure to put in place as well as the expertise of the CRO. Ensure regular updates provided to GMAT 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.
• GMA LT responsibility
  Member of the GMA LT Oncology. Coordinate with the Global Medical Affairs Oncology Leadership team (GMA LT) to ensure efficient and transparent allocation of Clinical operation resources, assignment of activities in support of program/trial deliverables and individual development needs. Develop a hiring plan for GMA and oversee the hiring process.
  Accountable for keeping a resource model adapted to GMA to optimize resource allocation and reallocation according to growth of portfolio and change in strategies
  Align across franchise to ensure consistency in execution for all activities (CIS, EAP, IIS management). Interface optimally with QA, legal/compliance, Clinical Supply Organization, R&D CE, to seek input or feedback or alignment on a timely manner when needed
• Process/Policies
  Develop and implement process standards and tools to achieve excellence in trial operations and management. In collaboration key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance within GMA across compounds and projects. Serve as knowledge source for clinical operations staff on processes related to trial deliverables and coordinate knowledge sharing. Author/reviewer for clinical SOPs. Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable

Qualifications

Education Qualifications
Bachelor's Degree required; degree in life science/healthcare preferred.  Advanced degree preferred.

Experience Qualifications
10 or More Years of related overall experience required 
4 or More Years of pharmaceutical clinical research experience preferred 
4 or More Years people management and development experience, this may include management in a matrix environment. Global people management required
Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs preferred
mindset of putting the patient first, as well as have a values-driven leadership style where integrity drive all behaviors, decisions, and actions preferred
Strong management, interpersonal and problem solving skills preferred
Extensive knowledge of clinical development process, regulatory requirements and GCP. preferred
Proven capabilities in clinical operations process improvements preferred 
Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation preferred
Understand the importance to involve and include key stakeholders on a timely manner to ensure transparency, awareness in order to optimize the decision making process and timelines of implementation preferred
Medical/scientific knowledge of Oncology and/or Haematology preferred
Forward thinker looking to advance the mission and values of the company preferred
Demonstrated vendor and project management experience preferred
Ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions preferred
Proven ability to work with minimal supervision in a cross-functional matrix environment preferred
Demonstrate the ability to lead and influence others and work successfully in a matrix environment with internal and external team members preferred
highly organized and detail-oriented preferred


Travel Requirements
Ability to travel up to 20% of the time. Standard office based physical demands, minimal travel.