Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionAbbvie Clinical Data Strategy and Operations (CDSO) is best in class team within its cross-industry peer group, responsible for bringing people, process, and technology together to generate business value from clinical trials. Our operational model is exemplified through execution and innovation. The Director of Clinical Data Strategy & Operations (CDSO) oversees the Oncology therapeutic area. This critical role will contribute to the strategy for Oncology in collaboration with CDSO Therapeutic head TA and will also support the growth and development of the people within their organization.
Provide leadership and direction to the Clinical Data Management Operations team, ensuring alignment with organizational goals and objectives.Oversee the management of clinical data in assigned therapeutic areas, ensuring adherence to data management processes and regulatory requirements.Collaborate with cross-functional teams, including Clinical Development Operations, Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs, to ensure the integration and accuracy of clinical data.Mentor and support data management professionals, providing guidance, training, and performance evaluations to ensure the highest level of productivity and quality.Establish and maintain relationships with external vendors, ensuring effective communication and collaboration to meet project timelines and deliverables.Understand and streamline processes for maximum efficiency, ensuring they meet the needs of the organization and comply with industry standards.Monitor project budgets, resource allocation, and timelines to ensure successful execution of clinical data management activities.Stay updated with industry trends, best practices, and regulatory requirements related to clinical data management, and implement necessary changes to maintain compliance and enhance operational efficiency.Leads and manages both CRO/fully outsourced trials as well as in-house/functional service provider trials. QualificationsBachelor's degree in a scientific or related field, advanced degree preferred.Minimum of 12 years of experience in clinical data management, with exposure to multiple therapeutic areas.Proven experience in a leadership role overseeing clinical data management operations.Strong knowledge of industry standards, regulatory requirements, and best practices related to clinical data management.Understanding of clinical trial methodologies, data collection processes, and data analysis techniques.Demonstrated ability to lead and motivate a team, providing guidance and support.Strong collaboration and interpersonal skills, with the ability to communicate effectively with cross-functional teams, external vendors, and senior management.Problem-solving and decision-making abilities, with a track record of successfully resolving complex issues.Proficiency in Data Management Review systems and tools (i.e. JReview, Spotfire etc.) to enable effective data review as well as operational metrics.Proven track record in managing Functionally outsourced service providers and CROs. *Level is commensurate upon experience. There are 2 job openings: Director, Data Management Operations (Solid Tumor), Director, Data Management Operations (Hematology). Office locations: Lake County, IL, Florham, NJ, Boston, MA. Additional InformationApplicable 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 Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's 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. To learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html (US & Puerto Rico only).
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