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Associate Director, Project Management

3 months ago

Morrisville, United States WEP Clinical Full time

Job Description

Job Description Salary: Are you a professional with strong initiative and excellent problem-solving skills? Do you aspire to make a meaningful impact in the pharmaceutical industry, particularly in overseeing and executing critical projects? If so, we have an exciting opportunity for you Join our team at WEP Clinical as an Associate Director of Project Management and help us bring life-changing treatment solutions to patients worldwide. At WEP Clinical, our business is growing, and the career opportunities are limitless. We encourage our team to bring innovative ideas to the table. Join us and see how you can elevate your career while making a significant impact on the lives of patients

Role

Objectives:

The WEP Clinical Associate Director of Project Management is responsible for assisting with the oversight of program set up, implementation, and overall management of Expanded Access Programs (EAP) and/or Post-Approval Named Patient Programs (PA-NPP). The Associate Director is also responsible for the line management of assigned reports and for contributing to the development of departmental processes.

The ideal candidate for this role should be:

An excellent communicator A proactive leader who demonstrates initiative Highly adaptable An effective problem solver

Principal Duties and Responsibilities:

Lead and provide operational oversight for project management team. Responsible for project team’s training and development, as well as performance reviews. Assure project teams are managing programs in accordance with WEP Clinical SOPs and Policy’s. Oversee and manage regional and global programs with accountability for the successful delivery of projects on budget. Ensure all program project plans including timelines and budgets are developed in compliance with the Statement of Work (SOW). Proactively identify, evaluate, monitor, and mitigate program risks as well as communicate identified risks to WEP Clinical management and clients, as appropriate. Support WEP Clinical Business Development, Contracts and Finance teams with contracts, change orders and monthly invoicing. Oversee all project operations and services and ensure compliance to GMP/GDP, GCP/ICH, and regulatory requirements. Maintain current knowledge of US, UK, and EU regulations as well as GxP/ICH Guidelines for EAP/PA-NPP and clinical research. Develop, document, and update internal WEP Clinical processes required for consistency across programs, such as SOPs, working practices, and related forms. Produce update reports for Senior Management on the performance metrics of each program. Build and maintain positive client relationships. Oversee and lead WEP Clinical PM team with issue management and resolution as required. Identify new opportunities within existing client base and relay to BD team. Identify potential vendors and, in collaboration with WEP Clinical Quality, participate in the vendor evaluation and selection process. Assist in the development and delivery of proposals for bid defenses and capability presentations to prospective clients. Supports Contracts and Proposals with final project contract execution and change orders.

Qualifications:

Bachelor’s Degree (in a health or science field preferred). 5+ years’ experience in clinical research or project management, with at least three (3) to four (4) years direct clinical trial or Expanded Access Programs experience in a CRO or research related organization with at least one (1) year line management experience. Computer literacy and proficiency in Microsoft Office, as well as experience with an eTMF and CTMS. Ability to handle confidential information with complete discretion. Strong organizational skills and attention to detail. Ability and willingness to travel up to 20% of the time. Effective verbal and written communication skills. Knowledge of clinical research process from Phase I through regulatory submission. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Pro-active and solutions driven, with ability to meet multiple tasks and deadlines with a high level of accuracy. Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings. Ability to set baseline targets, track trends, and implement mitigation plans. Understanding of basic data processing functions, including electronic data capture. Working knowledge of current ICH GCP guidelines.

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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