Senior Associate, Process Excellence

Requisition Number: 7722

Position Title: Senior Associate, Process Excellence

External Description:

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.  

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!

External Description:

SUMMARY: The Senior Associate Central Planning  is a full-time position responsible for supporting the Central Department with a focus on ensuring consistency, predictability, and transparency in the delivery successful clinical studies across Global Clinical Development (GCD).The  Senior Associate ,Central Planning  is central to the onboarding and development of Global Clinical Development staff,  ensuring that the materials, training, tools and support for Project Management and project oversight are available, digestible and effective.  The materials include, but are not limited to, Standard Operating Procedures (SOPs), Working Instructions (WIs), Onboarding, and GCD training & orientation.

Central Planning is responsible for supporting project execution inclusive of project resourcing, project scheduling and demand, portfolio management and overall support and quality of project management processes.

 

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Lead GCD Onboarding and employee development programs, driving curriculum development and assuring quality and fitness for purpose of materials.

o            Develop and maintain documents, tools, and forms related to Central Planning and in support of GCD onboarding and development.

o            Develop, Deliver, and verify the effectiveness of necessary quality and process training.

 

• Partner with subject matter experts to generate and analyze information that will support the recommendations of solutions that address productivity, efficiency, complexity, and strategic opportunities, while enhancing the customer experience
• Design, document, and drive processes to ensure timely completion of projects with successful outcomes. Guide team members through the project and implementation process.
• Drive for high-quality results on any other deliverables as assigned.
• Participates in and supports multiple internal levels of management in the analysis and evaluation of initiatives, projects, and issues.
• Participate in efforts to implement ongoing process management mechanisms (process mapping, documentation, metrics, monitoring systems, and process control techniques)
• Help departments gather process data and data analysis to document change.
• Manage document control functions and maintain departmental document library.
• Assist with design, documentation, and review of Quality Management Documents inclusive of SOPs, Work Instructions, in collaboration with functional departments, as required.
• Support Central Planning and Project Planning & Administration departments with tasks as the pertain to quality and program initiatives, including but not limited to:

o            Meeting organization, preparation, conduct, and outputs

o            Assist with quality control checks and measures.

• Initiate and support improvements to enhance the efficiency and the quality of the work performed on assigned projects.

OTHER SKILLS AND ABILITIES:

• Strong leadership and problem-solving skills.
• Working knowledge of clinical research, ICH, GCP and FDA or EU directive regulations (as applicable.
• Proven cross-functional team leadership skills and the ability to influence others at all levels of an organization.
• Strong interpersonal skills in a fast-paced and rapidly changing environment.
• Excellent written and verbal communication skills.
• Ability to work independently and professionally communicate with internal and external counterparts.
• Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval.
• Ability to handle multiple tasks, including rapid response in generating new documents, forms, and tools.
• Strong organizational skills, especially around planning meetings.
• Strong attention to detail and communication nuances.
• Advanced skills in MS Office applications including Microsoft Word, Excel, PowerPoint, and Publisher.　
• Excellent spoken and written English skills as well as fluency of the language of the country of location.

REQUIREMENTS:

• Four-year college curriculum or university degree In lieu of degree, relevant skills, or equivalent experience.
• At least 2 years’ experience in clinical research
• Skill sets and proven performance equivalent to above

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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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Employment Type: Regular

Community / Marketing Title: Senior Associate, Process Excellence

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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