- Manage the daily operational activities in Puerto Rico of GPRD Phase I to IV clinical studies monitored by Abbvie in accordance with GCP/ICH guidelines and AbbVie SOPs.
- Ensures clinical trial activities are conducted according to the monitoring plan and are in accordance with project timeliness and company objectives. Anticipates and identifies site issues that could affect timeliness and develops alternative solutions.
- Assesses risk of issues raised by monitoring staff and understands their potential impact on operational and quality requirements and project timeliness. Elevates issues to appropriate AbbVie personnel and works to develop a resolution to reduce impact.
- Serve as a contact for clinical sites personnel and SM&M for study related questions. Works with the Clinical Project Teams to establish GPRD clinical trials in Puerto Rico, while Identifies new potential sites in Puerto Rico and perform the feasibility work, investigators identification and sites evaluation.
- Manage study start up activities that include essential documents preparation and collection and contracts and budgets negotiations. Local oversight of GPRD contractors.
- Clinical project planning to include assessment of clinical development team headcount, resource planning, project timeliness and effective utilization of budget.
- Effective communication of clinical projects related information including the planning and execution of meetings and presentations.
- Act as a pharmacovigilance back-up for the Affiliate Safety Representative.
- Bachelor's Degree required; medical/science/nursing background preferred. MS, MA, MBA, MPH desired.Minimum of 8 years clinical research experience, at least 1 year functioning in a lead capacity with mentoring/supervisory/leadership experience preferably in a country based capacity,At least 3 years experience in clinical site monitoring.Proven strong site management and monitoring skills. Relevant experience in multi-therapeutic areas desired. Good interpersonal skills.
- Excellent communication skills and ability to work effectively across departments with corporate and regulatory agencies.Ability to effectively train and mentor others with less experience.Excellent verbal and written communication and presentation skills in both English and Spanish. Proficiency with appropriate computer programs.Must have an advanced and thorough knowledge related to ICH/GCP guidelines and/or federal regulations, and applicable local regulations.
- Ability to work with multiple priorities in a work environment with frequent interruptions.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
