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Director, Data Management Operations (Solid Tumor or Hematology)

Company Description

AbbVie'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 TwitterFacebookInstagramYouTube and LinkedIn

Job Description

Abbvie 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 trial. 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 inhouse/functional service provider trials.

Qualifications

  • Bachelor'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 Information

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 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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What You Should Know About Director, Data Management Operations (Solid Tumor or Hematology), AbbVie

If you're an experienced leader in clinical data management, AbbVie is looking for a Director of Data Management Operations to join our team in Florham Park, NJ. This is a fantastic opportunity to step into a dynamic role where you'll oversee our clinical data management efforts in the Oncology therapeutic area, with a special focus on solid tumors and hematology. You'll be leading a talented team to ensure that our clinical data processes are not only compliant with regulatory standards but also efficient and innovative. This role allows you to collaborate closely with cross-functional teams—think Clinical Development, Biostatistics, and Regulatory Affairs—to guarantee that our data is integrated and accurate. You'll also play a pivotal role in mentoring and developing data management professionals, ensuring that they have the tools and guidance needed to thrive. With your expertise, you'll establish strong relationships with external vendors while being responsible for monitoring project timelines and budgets to ensure excellence in execution. At AbbVie, we are all about making a meaningful impact in people's lives, and as the Director, you will help shape the strategy for the future of oncology. Come be a part of our remarkable mission of delivering innovative medicines that address serious health issues and join us in making a difference!

Frequently Asked Questions (FAQs) for Director, Data Management Operations (Solid Tumor or Hematology) Role at AbbVie
What are the responsibilities of the Director, Data Management Operations at AbbVie?

The Director, Data Management Operations at AbbVie is responsible for providing leadership and direction to the Clinical Data Management Operations team, overseeing clinical data management processes in the oncology therapeutic area, collaborating with cross-functional teams, mentoring data management professionals, establishing vendor relationships, and ensuring compliance with industry standards.

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What qualifications do I need for the Director, Data Management Operations role at AbbVie?

To qualify for the Director, Data Management Operations position at AbbVie, candidates should possess a Bachelor's degree in a scientific or related field (advanced degree preferred), at least 12 years of experience in clinical data management, strong leadership experience, and a solid understanding of regulatory requirements and best practices.

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What skills are essential for the Director, Data Management Operations at AbbVie?

Essential skills for the Director, Data Management Operations at AbbVie include strong leadership and interpersonal abilities, effective collaboration skills, a problem-solving mindset, and proficiency with data management review systems to ensure effective data governance and operational metrics.

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What type of projects will the Director, Data Management Operations oversee at AbbVie?

The Director, Data Management Operations at AbbVie will oversee various projects related to clinical data management in oncology, including fully outsourced clinical trials as well as in-house trials, ensuring that all projects are executed efficiently and within compliance parameters.

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How can the Director, Data Management Operations contribute to AbbVie's mission?

The Director, Data Management Operations contributes to AbbVie’s mission by ensuring that clinical trials are executed with high-quality data management processes, which is critical for the successful development of innovative medicines that address serious health issues, ultimately improving patient outcomes.

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Common Interview Questions for Director, Data Management Operations (Solid Tumor or Hematology)
Can you describe your experience managing clinical data management operations?

When answering this question, discuss the scope of your previous roles, specific therapeutic areas you’ve managed, and how you ensured compliance with regulatory standards while driving operational efficiency.

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How do you ensure the accuracy of clinical trial data?

Here, emphasize your methods for data validation, cross-team collaboration, and your familiarity with relevant data management tools and systems. Provide examples of processes you've implemented in the past.

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What leadership strategies do you employ to mentor your team?

Discuss your approach to mentorship, including setting clear expectations, providing constructive feedback, and fostering a collaborative team environment where team members feel valued and motivated.

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How do you handle conflicts with cross-functional teams during a project?

Share your conflict resolution strategies, such as addressing issues directly, facilitating open communication, and finding common ground to ensure project continuity. Use specific examples if possible.

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What experience do you have with managing CRO relationships?

Talk about your past experiences working with Clinical Research Organizations, highlighting how you ensured that their deliverables met your team's standards and project timelines.

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Can you explain your understanding of data management regulatory requirements?

Provide a detailed overview of key regulatory frameworks relevant to clinical data management, expressing your commitment to staying updated with industry changes and implementing best practices.

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What metrics do you use to measure the success of data management operations?

Discuss the types of metrics you track, such as data quality indicators, project timelines, resource allocation efficiency, and how you've used these metrics to drive improvements.

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Describe a significant challenge you faced in data management and how you resolved it.

This is your chance to share a specific example, outlining the challenge, the steps you took to address it, and the positive outcomes that resulted from your actions.

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How do you ensure that team members are engaged and productive?

Discuss methods you use to keep your team engaged, such as providing professional development opportunities, recognizing achievements, and fostering an inclusive work environment.

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Why do you want to work as the Director, Data Management Operations at AbbVie?

Tailor your response to reflect your alignment with AbbVie’s mission and values. Highlight how your experience and goals fit with the direction of the company in the oncology therapeutic area.

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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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Full-time, on-site
DATE POSTED
December 3, 2024

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