Cary, North Carolina
about 1 month ago
VP of Clinical Operations and Data Management
Job Id: 8706
Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, 401K, paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Responsible to manage all aspects of clinical trials (Phases 1 to 4) including identification, vetting, selection and management of all vendors (CROs, clinical labs, contract monitors, medical writers, data management, etc.) associated with the planning, start-up, conduct, and closeout of company’s clinical trials.
- Responsible to provide leadership, strategic oversight, and guidance of Clinical Operations and Data Management to ensure quality, timeline, resources and budget goals are met.
- Responsible to establish performance indicators (e.g., site initiation, patient recruitment, data collection, query resolution, etc.) and monitor and communicate to ensure the successful execution of clinical trials.
- Responsible to represent all aspects of the department and provide updates as required to the R&D Portfolio and Project Leadership Committee, Executive Committee and Board of Directors as appropriate.
- Responsible to oversee, plan and implement quality checks for clinical projects.
- Responsible to develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of clinical projects.
- Responsible to oversee data management activities such as study start up, data management plans, UAT of clinical database, data reviews using risk-based monitoring, data cleaning and resolution of issues, database lock.
- Responsible to participate in relevant national/international medical conferences related to products and their disease states.
- Bachelors in Life Sciences, Nursing Licensure or Pharmacy required; an advanced degree (MS, PhD, or PharmD) is preferred.
- At-least 15 years of experience in clinical operations with a track record of developing, implementing, and leading early to late stage clinical trials.
- Experience in conduct of clinical trials in pulmonary diseases (pulmonary hypertension, idiopathic pulmonary fibrosis, etc.) is desirable.
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
- Experience with global drug development and NDA filing is preferred.
- Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
- Strong leadership and managerial skills that focus on teamwork and building alliances across functions and outside the company
- Experience in novel delivery systems and platform technologies is desirable
- Medical Insurance
- Dental Insurance
- Vision Insurance
Ask for: Aarti Manchanda
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.