Health Care

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Pharma-Cruiting Life Sciences Executive Search is seeking a Project Director Clinical Research for our generic pharmaceutical company client in North Jersey.  The incumbent will develops and manage day to day clinical operations and management of clinical trials which enables the planning, execution and reporting on multiple US/Global clinical studies in an efficient and effective manner.The Project Director will be a high performing individual who demonstrates a strong scientific/clinical background and a pharmaceutical/biotech clinical trial track record with accomplishment in a team setting.Essential Duties and Responsibilities include the following: •        Operational and execution management of multiple ongoing clinical studies. •        Responsible for supporting medical monitoring/reporting and company safety monitoring activities with triage for the VP Clinical Research North America (NA).o        Review clinical laboratory results looking for evidence of toxicity (or for evidence at baseline that patients with significant abnormalities are being enrolled inappropriately), which are brought to the attention of the VP Clinical Research NA immediately.•        Field clinical site questions during conduct of the clinical trial and when appropriate, involve the VP Clinical Research NA. •        Closely monitor and track clinical trial progress as appropriate and document as per GCP, IRB, US FDA guidance recommendations and company SOPs.•        Assist with clinical data review and will support the interpretation, reporting of results, and preparation for Health Authority submissions. •        Work closely with VP, Clinical Research and liaise with other internal & external stakeholders (CRO, data management, statistics, clinical operations, global medical safety, clinical supplies, project management, quality assurance and quality management). •        Participation in multi-disciplinary working groups and clinical teams for implementation of franchise business strategies. •        Responsible for the review of medical literature and may interact with clinical investigators with direction by the VP, Clinical Research NA. •        Assist in preparing for investigator meetings, advisory boards, briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results.•        Create and submit expense reports•        Schedule meetings and conference calls•        Create and maintain filing systems  •        Prepare and submit invoices for payment•        Assist with preparation of presentation materials •        Review and summarize miscellaneous reports and documents; prepare background documents and outgoing mail as necessary•        Prioritize and manage multiple projects simultaneously, and follow through on issues in a timely manner•        Track ongoing departmental expenses •        Other duties and projects as assignedQualifications:•        A minimum of a Bachelor's degree is required; Advanced degree (Nursing, MS, PhD or PharmD) preferred •        Requires a minimum of 5 years of clinical trial management development experience within the pharmaceutical industry. •        Experience in Internal Medicine. Diabetes, Infectious Disease or Metabolic clinical trial development management is required. •        Significant experience in supervising and managing clinical research programs is required. •        Other key qualifications include knowledge of GCP/ICH guidelines and US FDA regulations, experience with clinical trial design and basic knowledge of statistics.•        Strong interpersonal and communication skills are essential. •        Must demonstrate ability to operate in a matrix environment.•        Excellent organizational skills and attention to detail.•        Ability to multi-task and follow through on tasks a must.•        Ability to work and communicate effectively with others both inside and outside of our organization. •        Strong sense of teamwork, dignity, integrity and respect.•        Proficient experience in MS Word, Excel, PowerPoint and Lotus Notes.To apply: Please email cover letter and resume to ruth@pharmacruiting.com