Manager, Regulatory and Start-Up

Lifelancer
US - North Carolina - Durham
January 6, 2025
Management

About the job Manager, Regulatory and Start-Up

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 OverviewDirect 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

Bachelor's Degree Related field Req
6 years clinical research experience, including 3 years experience in a leadership capacity.
Equivalent combination of education, training and experience.
Full knowledge of drug development process
Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards
Strong knowledge of budget management and resourcing
Considerable working knowledge of medical terminology
Strong knowledge of Microsoft Office and e-mail applications
Effective communication, organizational, interpersonal, and leadership skills
Strong negotiation skills
Ability to independently coordinate and manage new processes
Ability to lead and motivate teams
Ability to handle management/personnel issues
Ability to work independently and to effectively prioritize tasks
Ability to work well within a matrix team environment
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

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.

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 ( ) 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.

Read the full job description and apply online on the recuiter's web-site

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