Country Study Mgmt-FDE

Job description

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities

The CountryStudy Management (CSM) role is responsible for providing clinical operational expertise to internal and external customers through ownership of regional/global level clinical trial (CT) management. The CSM will drive regional/global enrollment targets and will be responsible for project management and clinical operational oversight of regional/global study level deliverables.
The CSM will also contribute ideas to improve processes and manage change while supporting ongoing business objectives.

Business Deliverables
Core
· Be knowledgeable on the Global and Regional operating model and able to provide clinical operational guidance to the study teams.
· Attend trial meetings (i.e. critical chain network build, SD2e KO, CDIO Jams, PFT etc. ) when applicable to provide country/regional/global input and manage related communications
· Coordinate and facilitate regional input to early protocol development and study timelines to study teams during SD2e process.
· Attends Protocol Simulation (when applicable) to help identify protocol implementation challenges.
· Drives affiliates and TPOs to achieve the Enrollment Readiness and first patient to enter a study(FPV) .
· Work with the Clinical Operations Portfolio Manager (COPM), Clinical Development Consultant (CDC) / Clinical Development Liaison (CDL)/ Regional Research Manager (RRM), Clinical Trial Manager (CTM), Site Activation Manager (SAM), and if applicable Third Party Organisation (TPO) project manager(s) to drive Site Activation processes and enrollment.
· Provides project management oversight global/regional and/or country level study deliverables, including site activation timelines, tracking of enrollment, oversight of closure of non-performing sites process, and implementing country/regional/global enrollment risk plans
· Ensures global/regional and/or country level milestones are accomplished to plan (i.e., FPV, LPETx).
· Creates and Implements the enrollment strategy, resolves enrollment and retention related issues and escalates to the COPM and management any unresolved enrollment issues.
· Input intoinvestigator site communications (e.g., newsletter, enrollment updates).
· Provide study updates to the Clinical Development Consultant (CDC)/ Clinical Development Liaison (CDL)/ Regional Research Manager (RRM), Clinical Portfolio Manager (COPM), Clinical Operations Manager (COM), and management.
· Provide global/regional input into enrollment acceleration and patient retention programs, including vendor relationships and drive the implementation.
· After LPETx, provides high-level trial oversight until the end of Data base Lock (DBL). May provide more detailed oversight after LPETx when applicable (e.g. retention issues, protocol amendments, etc.).

Regional – specific deliverable

· Work with CTM and Global Study Training Manager (GSTM) to give global/regional input into the study training plan.
· Coordinates the approval to increase enrollment at the global/region/country level
· Requests approval to increase the out-of-pocket (OOP) expenses
· Ensures that country specific budgets are prepared and approved
· Reviews IMPACT to ensure it reflects the country / regional level status).Drive trial enrollment, site activation targets through project management and clinical operational oversight of /region/global level deliverables
· Provides Clinical operational expertise to internal and external customers across Regions with primarily focus on risk planning , site activation & enrollment mitigation
· Presents a global perspective with study teams to better represent different regions equally

Process Improvement/Change Management

· Actively seeks opportunities for innovative business solutions and implements as appropriate.
· Participates in organizational projects (i.e. Six Sigma, Next Generation Development, etc.).
· Drives shared learning between CSMs to ensure global consistency and achieve process improvements.

Business Development/External Focus

· Maintains familiarity with regulations and guidelines regarding site activation process and patient enrollment practices.
· Maintains active relationships and/or memberships with applicable research and disease-state organizations.

Additional Information

FDE Only-This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.

Need to travel periodically to AST/ISST and potentially other scientific/regional meetings
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Removal Date

17-May-2016

Desired profile

Basic Qualifications

· Bachelor's degree in a scientific or health-related field
· Minimum of 3 years clinical trial experience with a strong working knowledge of the clinical research process
· Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences

· Oncology experience preferred
· Strong leadership and networking skills to work in cross-functional and cross-cultural teams (internal & external)
· Strong self-management and organizational skills
· Excellent project management skills
· Strong problem solving and communication skills (both verbal and written)
· Ability to influence without authority
· Strong analytical skills
· Proficiency in use of project management tools such as Excel, Power Point, MS Project, risk assessment and contingency planning
· Previous affiliate experience
· Demonstrated ability to work effectively cross-culturally in a virtual work environment