Clinical Systems Project Manager

Who we are

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

*SUMMARY: Plans and manages the successful delivery of assigned clinical systems projects by ensuring high quality execution and work products and by meeting the established project budget and schedule*

*RESPONSIBILITIES:*

_Tasks may include but are not limited to:_

Plan project scope and timelines to ensure successful delivery by defining scope deliverable in shorter timelines (thereby breaking larger scope efforts into multiple smaller phased projects), by ensuring the availability of all necessary participants, and by identifying risks and corresponding mitigation plans
Provide oversight and accountability of deliverables, ensuring they meet Worldwide SOP's, current Good Clinical Practice (GCP) and other applicable regulations
For projects that are a part of a larger effort, collaborate with other project managers and key stakeholders to ensure the project timeline aligns with the overall timeline and where possible allows for minor adjustments that do not impact the overall timeline
Liaise with staff and management as applicable to manage project budgets
When applicable, ensure that vendor contracts, budgets, schedules, and deliverables align with the project needs
Proactively identify the incidence of additional scope and work with stakeholders to determine the appropriate course of action, raising change orders as needed
Continuously assess project status, reassess and revise risks, oversee issue documentation and escalation, and ensure the project team and stakeholders remain informed of project status, risks, and issues throughout the project (including both periodic project health updates as well as ad hoc communications for emerging impacts)
Collaborate with functional leads to identify, evaluate, and communicate project requirements, assign and revise assignment of resources, to interpret and resolve project issues, and to ensure all project objectives and work products are completed
Coordinate or execute resourcing change and task progress updates to the project resource management system
Coordinate and lead well-organized project meetings, and ensure minutes and action items are distributed
Apply general business expertise and/or seek and implement advice from appropriate subject matter experts to make informed decisions that lead to project success
Author the clinical systems project plan
Review and provide approval for project documents authored by other project team members or vendors, ensuring alignment with project objectives, Worldwide SOPs, and regulatory requirements
Ensure all project documentation is filed timely, is complete and accurate, and is signed as appropriate
Coordinate and ensure completion of user acceptance testing by appropriate stakeholders as required
Coordinate installation and operational qualification where applicable
Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required for projects that include study IRT delivery
Perform QC checks of manual database edits and other tasks where required
Provide oversight and support of assigned ongoing studies, including periodic on-call support when required
Provide first-line and second-line support where appropriate to clinical systems supported by the Clinical Systems Department
Coordinate the identification, documentation, and management of incidents that occur both within as well as outside of project delivery
Attend off-site Investigator Meetings and other types of project related meetings when required
Contribute to the identification, creation, and improvement of key performance indicators to identify actionable issues and opportunities for improvement
Compile and disseminate KPIs and other project metrics in alignment with project requirements and department standards for project metrics
Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
Contribute to the identification and implementation of process improvement initiatives
Perform other duties as assigned

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

*OTHER SKILLS AND ABILITIES: *

Ability to communicate concisely and effectively in both written and spoken English
Proficient client-facing skills
Proficient in the use of common office software
Self-motivated individual who can positively contribute to a team environment
High attention to detail
Ability to prioritize and handle multiple projects simultaneously
Flexible and able to use sound independent judgment and take initiative to assess information
Able to make effective decisions in a fast-paced, highly dynamic environment
Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems

*REQUIREMENTS:*

Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
Minimum 2 years' project management experience
Minimum of 5 years experience within CRO /pharma environment
Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
Contract Research Organization (CRO) or Pharmaceutical experience required
Possessing an in-depth understanding of project management expectations and practices with ability to work to and direct project plans
Familiar with IRT topics, including IRT study design, randomization methodologies, and just-in-time drug supply
Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
Proven ability to manage delivery of technology solutions deployed in clinical trials - such as IRT, RTSM, CTMS, EDC or other relevant technologies desired
Familiarity with GxP Validation Requirements

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law