Description
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 for one or more clinical studies. Assist with management of CFO and vendors such as CROs, Central Lab and other suppliers. Matrix management of functional area leads to meet study deliverables. Is aware of both internal and external business environments and their impact on studies. Escalates performance issues to management.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Assist CRM in planning and management of one or more clinical studies.
Assist CRM in the coordination of activities of cross-functional areas for the initiation, conduct and completion of one or more clinical studies on time and within budget. Coordinate study activities such as study design, protocol preparation, investigator selection, investigator meeting and contract preparation, vendor selection & CRF design and other activities to ensure on time completion of studies.
Assist CRM in assessment of study conduct. Assist in development of monitoring plan and monitor progress of study for adherence to the plan. Identify site issues that potentially impact valuable study data, ethical study conduct and ICH compliance. Respond to issues impacting study hygiene and make recommendations for corrective action. Liaison with functional areas contributing to the outcome of clinical studies.
Assist in the management of study completion activities. Oversee timely CRF collection, DCF resolution, site-close out activities and activities of other contributing functional areas. Coordinate activities of study vendors that are necessary for completion of study and availability of data for analysis.
Effectively communicate study information and escalation of issues to management. Propose corrective actions and contingency plans. Assist in planning and execution of meetings. May prepare and present at Investigator Meetings.
Prioritize activities to ensure goals of study/ies are met.
POSITION ACCOUNTABILITY / SCOPE:
Study Contributor
Assist in development and management of study and/or site budgets with CPRM. Critical review of vendor proposals to ensure study success. Initiate and assist in development of site and vendor contracts. Approve site/vendor payments and work with CPRM to ensure tracking of study expenditures.
Review Clinical Study Reports for accurate reflection of study conduct. May assist Medical Writing in data line listings, stat table review, or QC of report.
Requires some oversight and guidance.
Requirements
Minimum Education:
Bachelor’s Degree preferably in a science/nursing field or Associate’s degree/R.N. with relevant experience.
Minimum Experience / Training Required:
Must have 4+ years of direct clinical research experience as a CRA or related clinical research positions.
Must have demonstrated a high level of core and technical competencies of a CRA and/or in other related clinical research positions.
Must have exposure to all stages of a clinical study.
Competent in application of standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
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