Clinical Data Strategy & Operations Program Lead II (Remote Possible)

Initial Therapeutics, Inc.; North Chicago (IL); Hybrid; USD 106,000 - 203,000; Full time

Job summary

AbbVie is seeking a Data Scientist to join their best-in-class team. This role involves alignment with study strategies, managing projects, and ensuring adherence to regulatory guidelines. With a focus on innovation and process improvement, the position offers a chance to significantly impact clinical trials through effective leadership. Applicants should possess a Bachelor's degree and over 6 years of relevant experience, with a preference for candidates having a Master's degree and project management certifications.

Benefits

Comprehensive benefits package including 401(k)

Eligibility for short-term and long-term incentive programs

Paid time off (vacation, holidays, sick leave)

Qualifications

• 6+ years of pharma/clinical research/data management experience.
• In-depth understanding of clinical trial processes.
• Ability to influence others and effective coaching skills.

Responsibilities

• Leads the DSS Study Team, ensuring alignment with study strategies.
• Acts as the single point of contact for operational leads.
• Utilizes operational analytics to manage study progress.

Skills

Communication

Analytical Skills

Education

Bachelor's degree in business, management information systems, computer science, or life sciences

Master's degree preferred

Tools

Project Management Tools

Job description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

AbbVie Data Science is a best-in-class team within its cross-industry peer group, and isresponsible for bringing people, process, and technology together to generate business value fromclinical trials data. Our operational model is exemplified through execution and innovation. This roleis key to ensuring successful delivery against the program- and study-level accountabilities assignedto Data and Statistical Sciences, and includes the following job responsibilities:

• Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team.
• For assigned programs and studies, acts as single point of contact and accountable operationallead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engagesand connects global functional and cross-functional teams at the study level
• Interacts with and influences cross-functional team members to achieve program objectives
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and developsoptions and solutions.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies relatedto clinical development. If assigned, participates as the DS study owner in regulatory inspectionsand internal quality audits
• Participates in oversight of vendors and provides feedback related to clinical trial operations,issues, and trends in performance
• Responsible for coaching and mentoring team members
• Leads DSS innovation and process improvement initiatives and participates in cross-functionalinitiatives
• Conducts study execution lessons learned across functions
• May include indirect supervision of employee as well as supervision of work of contract resources

Qualifications

To be successful in this role, you should have a Bachelors degree in business, management information systems, computer science, life sciences or an equivalent. AMasters degree is preferred. PMP Certification or Lean Six Sigma Green Belt desired.

Qualified candidates must also have/demonstrate:

• 6+ years of pharma / clinical research / data management / health care experience or8+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and clinical technology. Management of a clinicaltrial from initiation through to completion in a lead role is preferred.
• Performance as a functional leader
• Ability to influence others without direct authority
• Ability to successfully coach / mentor in a matrix environment
• Effective communication skills
• Effective analytical skills

While there is a preference to have someone who can work from one of our sites, remote work is possible.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. Salary:$106,500 - $202,500

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://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