Director of Project Management - US

Clinigen•Malvern, PA

17h•Hybrid

About The Position

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. This position maintains and enhances the US Project Management Department through strategic planning, evaluating workload over different sites and team members. Ensure that objectives are achieved in accordance with established budgets and customers satisfaction. Standardize practices and procedures across the US and EU locations to be able to shift work and resources and gain efficiencies over the different sites. Manage resources to deliver customers on-time. This role will be hybrid with 3 days onsite presence required 2 days remote.

Requirements

Bachelor's Degree
4+ Years of previous management experience
8+years of work experience related to the knowledge of principles and practices involved in cGMP and Clinical Trial Management or any equivalent combination of education, training and/or experience
Possess a detailed proactive approach to management in problem solving of daily operations
Ability to lead, coach and mentor employees to provide direction in resolving issues
Must possess a detailed proactive approach to management in problem solving of daily operations
Exceptional oral and written communication skills and active listening ability
Excellent time management skills and ability to adapt quickly in a fast paced, changing environment
Self-motivated learner with demonstrated ability to take initiative and evaluate situations to find solutions
Confidentiality of all clients’ proprietary and pharmaceutical related information is essential

Responsibilities

Coordinate with the Business Development team client contract creation specifications
Oversee the Project Managers as needed with managing the project design and implementation structure of clinical studies including, but not limited to, packaging and labeling, dispensing, and distribution of clinical trial material and ancillary supplies.
Oversee Project Managers in the creation, review and approval of processing documents and schedules, while adhering to client specific needs and timelines.
Ensure accurate billing and documentation of project planning hours and activities
Acts as a liaison between clients and CSM and travels as needed to client locations
Partner with other team members in Operations to maintain and track outstanding requests
Work closely with the US Team Leads to ensure consistency is maintained and identify areas for improvement
Work closely with EU Project Management Director/Team Leads to ensure Project Management Processes are harmonized
Work closely with EU Project Management Team to address any issues that may arise
Delegate, provide instruction, train and provide oversight to direct reports
Partner with Quality Assurance to develop or revise SOPs, Work Instructions and Processing Protocols

Benefits

The culture.
Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that.
We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
The transparency with leadership.
All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform.
We use this feedback to inform our actions and decisions.
We’ve been able to take steps to continuously improve how we do things at Clinigen.
The benefits.
We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.
EEO.
Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.