What are the responsibilities and job description for the Manager, Regulatory and Start-Up position at Lifelancer?
Job Description
Job Description
Job Title : Manager, Regulatory and Start-Up
Job Location : Durham, NC, USA
Job Location Type : Remote
Job Contract Type : Full-time
Job Seniority Level :
Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Essential Functions
- Oversee the execution of Site Activation (including pre-award / bid defense activities) and / or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and / or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy / expectations and parameters for submissions and all necessary authorizations
- identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy / expectations for maintenance of clinical study approvals, authorizations and review / negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations / training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
Qualifications
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https : / / jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https : / / jobs.iqvia.com / eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https : / / jobs.iqvia.com / covid -19-vaccine-status
The potential base pay range for this role, when annualized, is $89,600.00 - $149,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and / or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and / or other forms of compensation may be offered, in addition to a range of health and welfare and / or other benefits.
Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https : / / lifelancer.com / jobs / view / ec87648a73f02be287d2b0f96ee96de7
Apply on Lifelancer Platform
Salary : $89,600 - $149,300
