Program Lead II, Data Management - Oncology (Remote Opportunities)
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is
responsible for bringing people, process, and technology together to generate business value from
clinical trials data. Our operational model is exemplified through execution and innovation. This role...
is key to ensuring successful delivery against the program- and study-level accountabilities assigned
to Data and Statistical Sciences.
Responsibilities:
Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
Oversee all EDC,and IRT vendor contracts for assigned clinical trials
Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members daily tasks and timelines.
Manages 4 to 7 clinical trial startups concurrently
Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials
Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive
Response Technology (IRT) vendors for assigned clinical trials
Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. Manage any internal quality assurance audit for assigned clinical trials
Qualifications:
Bachelors degree in business, management information systems, computer science, life sciences
or equivalent. Masters preferred. PMP Certification or Lean Six Sigma Green Belt desired.
Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
In-depth understanding of clinical trial processes and clinical technology. Management of a clinical
trial from initiation through to completion in a lead role is preferred
Demonstrated performance as a functional leader
Demonstrated ability to influence others without direct authority
Demonstrated ability to successfully coach / mentor in a matrix environment
Demonstrated effective communication skills
Demonstrated effective analytical skills
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
Apply Now
responsible for bringing people, process, and technology together to generate business value from
clinical trials data. Our operational model is exemplified through execution and innovation. This role...
is key to ensuring successful delivery against the program- and study-level accountabilities assigned
to Data and Statistical Sciences.
Responsibilities:
Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
Oversee all EDC,and IRT vendor contracts for assigned clinical trials
Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members daily tasks and timelines.
Manages 4 to 7 clinical trial startups concurrently
Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials
Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive
Response Technology (IRT) vendors for assigned clinical trials
Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. Manage any internal quality assurance audit for assigned clinical trials
Qualifications:
Bachelors degree in business, management information systems, computer science, life sciences
or equivalent. Masters preferred. PMP Certification or Lean Six Sigma Green Belt desired.
Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
In-depth understanding of clinical trial processes and clinical technology. Management of a clinical
trial from initiation through to completion in a lead role is preferred
Demonstrated performance as a functional leader
Demonstrated ability to influence others without direct authority
Demonstrated ability to successfully coach / mentor in a matrix environment
Demonstrated effective communication skills
Demonstrated effective analytical skills
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
Apply Now