AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
Primary Job Function
Assist CRM in managing individual clinical studies (Therapeutic Area: Oncology). May include management of CFO and vendors such as CROs, Central Lab and other suppliers. Assist in CSMS activities and/or reporting of study information and metrics.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Assist CRM in completion of activities required for planning and execution of a clinical study.
Assist CRM in the planning and completion of activities for the initiation, conduct and completion a clinical study. Assist in study activities such as preparation of protocol and informed consent, investigator/site selection, investigator meeting and contract preparation, vendor review, CRF design and other activities to ensure on time completion of studies.
Assist CRM in assessment of study conduct. Identify site issues that potentially impact evaluable study data, ethical study conduct and ICH compliance.
Review relevant sections of Clinical Study Reports for accurate reflection of study conduct.
Participate in study completion activities. Oversee timely data collection/ DCF resolution, site-close out activities and activities of other contributing functional areas. Assist in coordination of activities of study vendors that are necessary for completion of study and availability of data for analysis
Prepare and communicate study information. Escalate issues to management. Assist in planning and execution of meetings. May prepare and present at Investigator Meetings
Prioritize activities to ensure study timelines are met.
Position Accountability / Scope
Assist in development of study/site budgets and vendor contracts. Approve site/vendor payments and work with CPRM to ensure tracking of study expenditures.
Requires moderate level of oversight and guidance.
Bachelor’s Degree required; medical/science/nursing background is preferred
MS, MA, MBA, MPH desired
Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations
- Minimum of 5 years of clinical related experience, of which at least 3 years must be in clinical research monitoring
- Strong site management and monitoring skills
- Experience in multi-therapeutic areas desired
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
Strong ability to work independently in a geographic region with minimal supervision
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Excellent verbal and written communication skills
- Acute observational skills, analytical and conceptual capabilities
- Exhibit high level of flexibility when facing changes in the work environment
- Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications
- Working knowledge and experience with electronic data capture systems and clinical trials management systems
Minimum Experience / Training Required
The RS-CRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. They use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action taken at the clinical site is properly documented.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 15 % of the Time