Associate Consultant Clinical Trial Management - FDE
Company Name:
Lilly
9993BR
Title Associate Consultant Clinical Trial Management - FDE
City Bridgewater
State / Province New Jersey
Position Locale Local / Onsite
Location Details Bridgewater, NJ
Company Overview
ImClone Systems LLC is a leader in therapeutic monoclonal antibodies and committed to changing the world of cancer care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of tumor types. Founded in 1984, ImClone has a rich culture of discovery and deep expertise in oncology. Following its acquisition by Eli Lilly and Company in 2008, ImClone is accelerating its antibody pipeline development by leveraging Lilly''s global capabilities. ImClone''s pipeline has several molecules in mid- to late-stage clinical development targeting a variety of cancers.
Responsibilities
Project Management and Clinical Trial Leadership
Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:
Timeline - Develop and track overall trial timeline by networking, gaining alignment and integrating inputs across functions and geographies.
Use the change control process to communicate changes.
Risk - Assess, identify and monitor trial-level risks.
Incorporate both scientific knowledge and trial process considerations to create trial-level risk mitigation and contingency plans.
Budget - Understand the cross-functional, trial-level budget components.
Create and monitor the overall budget and assumptions using financial tracking tools.
Use the change control process to communicate changes.
Routinely network with molecule team, including the Clinical Project Management Consultant/Associate (CPM) on trial-level budget status and changes.
Scope - Understand the scope of work required to complete the clinical trial successfully.
Monitor the status and make adjustments and changes as needed to meet the deliverables of the trial.
Facilitate local, regional and/or global, cross-functional study team meetings throughout study development and execution to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
Manage relationships and serve as a single point of contact and central owner of trial communication.
Apply problem-solving skills to complex issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
Make timely decisions and maintain a solution-oriented approach to conducting daily business by utilizing cross-functional and clinical trial management expertise.
Maintain knowledge of sourcing strategies and provide Third Party Organization (TPO) oversight, including:
Understand TPO selection and qualification process. Review TPO bids and leverage Lilly s external sourcing group to drive selection decisions.
Create and manage work plan and budgets.
Manage activities based on operations guides with strategic partners (functional sourcing relationships).
Understand the correlation between outsourced scope of work and the trial budget to evaluate and communicate the financial status.
Effectively communicate and build positive relationships with sourcing partners and ensure timely resolution of issues.
Monitor performance metrics with TPO to ensure quality delivery, make necessary adjustments and document TPO oversight. Clinical Trial Process Expertise
Partner with the Global Clinical Operations organization on enrollment strategy and planning, monitor trial-level enrollment, evaluate impact to overall trial deliverables and partner with Global Clinical Operations to initiate contingency planning, including patient recruitment and retention programs .
Leverage expertise to identify areas of process breakdowns, assess situations and propose approaches that impact ability to deliver the clinical trial - with quality, on time and within scope and budget.
Share process learnings in order to benefit the Lilly portfolio.
Coach peers, cross-functional team members and TPOs on aspects of clinical trial process (development and execution).
Anticipate and resolve clinical trial issues .
Report, manage and interpret information for the clinical trials, including completeness and accuracy across multiple business systems and tools.
Apply expertise and knowledge of global/local regulations and Good Clinical Practice (GCP) to achieve inspection readiness.
Detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc) to arrive at the best solution.
Demonstrate understanding of drug development process.
Acknowledge inter-relatedness of cross-functional activities and understands the impact of project decisions on the big picture.
Maintain clinical trial process expertise across functional teams, geographies and external partners and make decisions on process and issues affecting study development and execution.
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Coordinate and participate in consultant/advisory board meetings as needed.
Externally focused and up-to-date with current literature on the target, competitor compound information and industry trends.Scientific Expertise
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Coordinate and participate in consultant/advisory board meetings as needed.
Externally focused and up-to-date with current literature on the target, competitor compound information and industry trends.Direct Site Management (if applicable)
Perform direct site management (DSM), if applicable, for human pharmacology and/or therapeutic exploratory clinical trials, including:
Partner with internal business partners to identify, qualify and select sites, draft investigator site budgets and initiate contract or Letter of Agreement (LoA)
Interact closely with the investigator sites to plan and implement the trial
Ensure compliance with the protocol and completion of trial deliverables according to agreed timelines
Manage site budget and investigator payments
Coordinate site initiation, monitoring and close out visits with assigned monitor/CRA.
Review monitoring reports as applicable and ensure resolution/follow up of data queries and monitoring issues.
Escalate unresolved quality and/or performance issues as necessary.
Basic Qualifications
Bachelors or University degree (scientific or health-related field preferred)
Three years clinical research experience
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
Prior clinical trial site-level experience
Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise)
Knowledge of regulations and guidelines that apply to the conduct of clinical trials Applied knowledge of project management methodology, processes and tools
Demonstrated ability to work cross-culturally with global colleagues and with TPOs
Ability to establish and manage relationships
Previous experience working in cross-functional teams or projects
Effective and influential communication skills
Solid self-management and organizational skills
Demonstrated ability to manage complex situations through problem-solving , critical thinking and navigating ambiguity
Flexibility to adjust to altered priorities
Additional Information
This position is not permanent. It is for a fixed duration for up to 4 years.
Eli Lilly and Company, Lilly USA LLC, affiliates and our wholly owned subsidiaries including ImClone Systems (collectively, Lilly ) are EEO/Affirmative Action Employers, and do not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
Removal Date 29-Jul-2014Estimated Salary: $20 to $28 per hour based on qualifications.
Lilly
9993BR
Title Associate Consultant Clinical Trial Management - FDE
City Bridgewater
State / Province New Jersey
Position Locale Local / Onsite
Location Details Bridgewater, NJ
Company Overview
ImClone Systems LLC is a leader in therapeutic monoclonal antibodies and committed to changing the world of cancer care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of tumor types. Founded in 1984, ImClone has a rich culture of discovery and deep expertise in oncology. Following its acquisition by Eli Lilly and Company in 2008, ImClone is accelerating its antibody pipeline development by leveraging Lilly''s global capabilities. ImClone''s pipeline has several molecules in mid- to late-stage clinical development targeting a variety of cancers.
Responsibilities
Project Management and Clinical Trial Leadership
Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:
Timeline - Develop and track overall trial timeline by networking, gaining alignment and integrating inputs across functions and geographies.
Use the change control process to communicate changes.
Risk - Assess, identify and monitor trial-level risks.
Incorporate both scientific knowledge and trial process considerations to create trial-level risk mitigation and contingency plans.
Budget - Understand the cross-functional, trial-level budget components.
Create and monitor the overall budget and assumptions using financial tracking tools.
Use the change control process to communicate changes.
Routinely network with molecule team, including the Clinical Project Management Consultant/Associate (CPM) on trial-level budget status and changes.
Scope - Understand the scope of work required to complete the clinical trial successfully.
Monitor the status and make adjustments and changes as needed to meet the deliverables of the trial.
Facilitate local, regional and/or global, cross-functional study team meetings throughout study development and execution to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
Manage relationships and serve as a single point of contact and central owner of trial communication.
Apply problem-solving skills to complex issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
Make timely decisions and maintain a solution-oriented approach to conducting daily business by utilizing cross-functional and clinical trial management expertise.
Maintain knowledge of sourcing strategies and provide Third Party Organization (TPO) oversight, including:
Understand TPO selection and qualification process. Review TPO bids and leverage Lilly s external sourcing group to drive selection decisions.
Create and manage work plan and budgets.
Manage activities based on operations guides with strategic partners (functional sourcing relationships).
Understand the correlation between outsourced scope of work and the trial budget to evaluate and communicate the financial status.
Effectively communicate and build positive relationships with sourcing partners and ensure timely resolution of issues.
Monitor performance metrics with TPO to ensure quality delivery, make necessary adjustments and document TPO oversight. Clinical Trial Process Expertise
Partner with the Global Clinical Operations organization on enrollment strategy and planning, monitor trial-level enrollment, evaluate impact to overall trial deliverables and partner with Global Clinical Operations to initiate contingency planning, including patient recruitment and retention programs .
Leverage expertise to identify areas of process breakdowns, assess situations and propose approaches that impact ability to deliver the clinical trial - with quality, on time and within scope and budget.
Share process learnings in order to benefit the Lilly portfolio.
Coach peers, cross-functional team members and TPOs on aspects of clinical trial process (development and execution).
Anticipate and resolve clinical trial issues .
Report, manage and interpret information for the clinical trials, including completeness and accuracy across multiple business systems and tools.
Apply expertise and knowledge of global/local regulations and Good Clinical Practice (GCP) to achieve inspection readiness.
Detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc) to arrive at the best solution.
Demonstrate understanding of drug development process.
Acknowledge inter-relatedness of cross-functional activities and understands the impact of project decisions on the big picture.
Maintain clinical trial process expertise across functional teams, geographies and external partners and make decisions on process and issues affecting study development and execution.
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Coordinate and participate in consultant/advisory board meetings as needed.
Externally focused and up-to-date with current literature on the target, competitor compound information and industry trends.Scientific Expertise
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation.
Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Coordinate and participate in consultant/advisory board meetings as needed.
Externally focused and up-to-date with current literature on the target, competitor compound information and industry trends.Direct Site Management (if applicable)
Perform direct site management (DSM), if applicable, for human pharmacology and/or therapeutic exploratory clinical trials, including:
Partner with internal business partners to identify, qualify and select sites, draft investigator site budgets and initiate contract or Letter of Agreement (LoA)
Interact closely with the investigator sites to plan and implement the trial
Ensure compliance with the protocol and completion of trial deliverables according to agreed timelines
Manage site budget and investigator payments
Coordinate site initiation, monitoring and close out visits with assigned monitor/CRA.
Review monitoring reports as applicable and ensure resolution/follow up of data queries and monitoring issues.
Escalate unresolved quality and/or performance issues as necessary.
Basic Qualifications
Bachelors or University degree (scientific or health-related field preferred)
Three years clinical research experience
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
Prior clinical trial site-level experience
Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise)
Knowledge of regulations and guidelines that apply to the conduct of clinical trials Applied knowledge of project management methodology, processes and tools
Demonstrated ability to work cross-culturally with global colleagues and with TPOs
Ability to establish and manage relationships
Previous experience working in cross-functional teams or projects
Effective and influential communication skills
Solid self-management and organizational skills
Demonstrated ability to manage complex situations through problem-solving , critical thinking and navigating ambiguity
Flexibility to adjust to altered priorities
Additional Information
This position is not permanent. It is for a fixed duration for up to 4 years.
Eli Lilly and Company, Lilly USA LLC, affiliates and our wholly owned subsidiaries including ImClone Systems (collectively, Lilly ) are EEO/Affirmative Action Employers, and do not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
Removal Date 29-Jul-2014Estimated Salary: $20 to $28 per hour based on qualifications.
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