Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Purpose:

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into
medicine for our patients and leveraging new advanced capabilities to drive industry leading
performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning
AbbVie as the choice in clinical trials.
Focus on site clinical research that ensures appropriate conduct of the trial while driving
improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities:

• Considered as the primary point of contact for the investigative site. High level of competency orexperience in providing contextual information on the clinical trials, connects stakeholder to theinvestigative sites and strengthens AbbVies positioning.

• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trialprogram, protocol and patient treatment principles for the trial ensuring a trusted partnership.

• Conducts site evaluation, site training, routine, and site closure monitoring activities withcompliance to the protocol and monitoring plans, in accordance with applicable regulations, GoodClinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), andquality standards, ensuring safety and protection of study subjects.

• Advanced understanding of site engagement and ability to customize site engagement strategy forassigned study (ies). Gather local/site insights and utilize site engagement tools such as theCustomer Relationship Management (CRM) tool, to report/track progress and measure impact ofthat strategy.

• Advanced level of competency connecting the study protocol, scientific principles and clinical trialrequirements to the day-to-day clinical trial execution activities. Evaluate and ensure effectiverecruitment and retention techniques/plans based on the patient disease journey.

• Develop solidknowledge of therapeutic area, asset and clinical landscape / patient journey to enable successfulpatient recruitment and overall protocol compliance.

• Possesses experienced level of competency to mentor and train less experienced CRAs on variousaspects of work and provides input into their development. May participate in global/local taskforces and initiatives. Responsible for activities as assigned by manager.

• Responsible for continuous risk-assessment proactively, and in collaboration with CentralMonitoring team, monitor activities conducted by clinical sites to detect early overall studyperformance or patient safety issues.

• Advanced ability to think critically to resolve site risk signals while having robust understanding ofsite processes to drive study execution. Ensures preventative and corrective action plans are putinto place, as needed, to mitigate risk and promote compliance using a customer centricapproach.

• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis.Potential sites may be identified through networking or internal AbbVie requests to assist in theplacement of planned clinical studies with qualified investigators.

• Ensures quality of data submitted from study sites and assures timely submission of data, includingappropriate reporting and follow-up for all safety events by site personnel. Ensures audit andregulatory inspection readiness at assigned clinical site at all times. Manages investigator paymentsas per executed contract obligations, as applicable.

Qualifications

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.

• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with riskbasedmonitoring approach, onsite and offsite monitoring.

• Knowledge of appropriate therapeutic area indications is preferred with the ability to understandand apply scientific concepts as they relate to the conduct of clinical trials.

• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCPGuidelines and applicable policies.

• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.

• Demonstrate strong planning and organizational skills and the ability to work effectively andefficiently in a dynamic environment with competing projects and deadlines.

• Advanced ability to leverage technology, tools and resources to provide customer centric supportbased on the health of the site.

• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills,with ability to establish and leverage site relationships and trusted partnerships throughengagement, motivation, and training.

• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.

• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.

• Self-motivated individual focused on delivering timely and quality outcomes in a fast-pacedenvironment.

Additional Information

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