Associate Director Project Management

7 days ago

Raleigh, United States WEP Clinical Full time

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.

What We Offer:

Medical, dental, and vision insurance, HSA, FSA Group short-term and voluntary long-term disability insurance Group life insurance 401K safe harbor plan and company match Paid vacation, holiday, sick, and volunteer time Paid maternity & paternity leave, Education assistance

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Expanded Access Programs (EAPs) Open Label Extension (OLE) Named Patient Programs (NPPs) Clinical Trial Supplies (Comparator & Ancillaries) Wren Nursing (Clinical Trial Home Nursing & Clinical Education) Hospital Supply of Unlicensed Medicines

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.

#J-18808-Ljbffr

  • Project Manager

    4 weeks ago

    Raleigh, United States Food Management Search Full time

    The Project Manager directs the company’s construction activities on heavy highway projects, as the senior on-site company representative, maintaining client and home office liaison and ensuring compliance with contractual obligations on a large complex project or several small projects. Coordinates, plans and supervises field staff, subcontractors and...

  • Associate Director

    1 week ago

    Raleigh, North Carolina, United States Maxim Recruitment Ltd Full time

    Ref MAX10117 Consultant Nilam Modhwadia Region North and Scotland Location Manchester Salary Up to £110k (DOE) Job Posted 08/05/2024 Type Permanent Status Live: Interviewing now An exciting Associate Quantum Director job in the construction sector to join a large multidisciplinary consultancy in their Manchester office.Project Details The client in question...

  • Associate Director of Member Programs

    1 month ago

    Raleigh, United States CORPS NETWORK Full time

    American Conservation Experience (HQ/Southwest) Associate Director of Member Programs JOB DETAILS Actively Recruiting : Yes Position title : Associate Director of Member Programs Type of Position : Staff (Full-Time) Town, City, Park, etc : Fletcher State / Territory : North Carolina Benefits : Health Insurance Project/Program Focus : Other American...

  • Associate Director of Member Programs

    5 days ago

    Raleigh, United States CORPS NETWORK Full time

    American Conservation Experience (HQ/Southwest) Associate Director of Member Programs JOB DETAILS Actively Recruiting : Yes Position title : Associate Director of Member Programs Type of Position : Staff (Full-Time) Town, City, Park, etc : Fletcher State / Territory : North Carolina Benefits : Health Insurance Project/Program Focus : Other American...

  • Project Engineer

    1 month ago

    Raleigh, United States Project Farma Full time

    Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering,...

  • Project Manager

    4 weeks ago

    Raleigh, United States Raleigh Radiology Full time

    Job DescriptionJob DescriptionDescription:A. This position is located at Raleigh Radiology’s Business Support Office location, may require travel to any Raleigh Radiology location, or may be remote.B. The Project Manager (PM) is responsible for planning, organizing, and directing the completion of assigned projects for the organization while ensuring these...

  • Project Manager

    3 weeks ago

    Raleigh, United States Raleigh Radiology Full time

    Job DescriptionJob DescriptionDescription:A. This position is located at Raleigh Radiology’s Business Support Office location, may require travel to any Raleigh Radiology location, or may be remote.B. The Project Manager (PM) is responsible for planning, organizing, and directing the completion of assigned projects for the organization while ensuring these...

  • Associate Director

    5 days ago

    Raleigh, United States Maxim Recruitment Ltd Full time

    Ref MAX10117 Consultant Nilam Modhwadia Region North and Scotland Location Manchester Salary Up to £110k (DOE) Job Posted 08/05/2024 Type Permanent Status Live: Interviewing now An exciting Associate Quantum Director job in the construction sector to join a large multidisciplinary consultancy in their Manchester office. Project Details The client in...

  • Associate Director

    2 months ago

    Raleigh, United States North Carolina State University Full time

    The Associate Director will serve as a leader within the Institute, working in conjunction with and supporting the Institute Director in furthering the Institutes mission and goals. The Associate Director will be responsible for the oversight of hig Director, Associate, Climate Change, Research, Commercial Driver, Management, Education, Science

  • Community Manager

    2 days ago

    Raleigh, United States Community Association Management, Limited Full time

    Job DescriptionJob DescriptionThe Community Manager is an integral role within the organization and serves as a pillar for the Homeowners Associations we serve. The incumbent is responsible for effectively building and sustaining relationships with HOA Board Members within their assigned portfolio. Community Managers must have strong communication and...

  • Associate Director, Regulatory Operations

    1 week ago

    Raleigh, North Carolina, United States Asklepios Biopharmaceutical Full time

    Associate Director, Regulatory Operations page is loaded Associate Director, Regulatory Operations Apply locations US Remote NC US Remote PA time type Full time posted on Posted 18 Days Ago job requisition id R24-69 Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of...

  • Director of Project Finance

    4 weeks ago

    Raleigh, United States Cinterra Full time

    Job DescriptionJob DescriptionDescription:Director of Project FinanceSummary: In this position, you will play an integral role by serving as the Director of Project Finance partnering with our Renewables Energy Solutions Business Line to lead a best-in-class Project Finance Organization. You will be responsible for all aspects associated with the planning,...

  • Director of Project Finance

    3 weeks ago

    Raleigh, United States Cinterra Full time

    Job DescriptionJob DescriptionDescription:Director of Project FinanceSummary: In this position, you will play an integral role by serving as the Director of Project Finance partnering with our Renewables Energy Solutions Business Line to lead a best-in-class Project Finance Organization. You will be responsible for all aspects associated with the planning,...

  • Project Director

    4 weeks ago

    Raleigh, United States Page Southerland Page Full time

    Overview: We are hiring a Project Director specific to our Higher Education sector for our Raleigh, NC office. At Page, we promise design that makes lives better. Were actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the...

  • Project Director

    1 month ago

    Raleigh, United States Page Southerland Page, Inc Full time

    Overview We are hiring a Project Director specific to our Higher Education sector for our Raleigh, NC office. At Page, we promise design that makes lives better. We’re actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the...

  • Project Director

    2 days ago

    Raleigh, United States Page Full time

    Overview We are hiring a Project Director specific to our Higher Education sector for our Raleigh, NC office. At Page, we promise design that makes lives better. We’re actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the...

  • Project Director

    3 weeks ago

    Raleigh, United States Page Southerland Page, Inc Full time

    Overview We are hiring a Project Director specific to our Higher Education sector for our Raleigh, NC office. At Page, we promise design that makes lives better. We’re actively seeking talented people to join an empowered employee environment. Page provides architecture, engineering, interiors and consulting services on large, complex projects around the...

  • Associate Creative Director

    5 days ago

    Raleigh, United States Gelia Full time

    Have you worked hard to become a creative powerhouse, pushing boundaries to bring visionary ideas to life? Do you see beyond the specs to raise your work to a different level? Do you participate with confidence in high-level brainstorming sessions, ready to take those innovative ideas and make them stunning realities? If so, you’d love Gelia. We don’t...

  • Associate Creative Director

    19 hours ago

    Raleigh, United States Gelia Full time

    Have you worked hard to become a creative powerhouse, pushing boundaries to bring visionary ideas to life? Do you see beyond the specs to raise your work to a different level? Do you participate with confidence in high-level brainstorming sessions, ready to take those innovative ideas and make them stunning realities?  If so, you’d love Gelia. We don’t...

  • Global Associate Director/Director, Quality Assurance

    2 weeks ago

    Raleigh, United States Merz North America Full time

    Global Associate Director/Director, Quality Assurance Job Category : Research and Development Requisition Number : GLOBA003455 Apply now Posted : December 18, 2023 Full-Time Locations Showing 1 location Description The Global Associate Director/Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality...