Senior-Project-Manager, Clinical-Project-Manager, Oncology-Project-Manager Jobs

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!

What the Project Management department does at Worldwide

Worldwide Clinical Trials Project management is the perfect blend of operational rigor and therapeutic expertise, with a client-focused approach. Our Global Project Leads (GPLs) and Clinical Project Managers (CPMs) expertly guide our project teams to deliver with high quality, focusing on “doing it right the first time”.

The Project Management team is engaged in all aspects of the trial collaborating with scientific and therapeutic leadership, coordinating across project teams, and providing flexible, innovative and proactive solutions. At Worldwide, you will be dedicated to a specific therapeutic area which will not only give you an opportunity to develop in depth global operational expertise, but also benefit from exceptional scientific and medical background that our experts bring.

What you will do

• Senior Project Manager (SPM) is responsible for the overall coordination and management of clinical trials from start-up through closeout activities.

• Directs the technical, financial and operational aspects of the projects -- thus securing the successful completion of clinical trials. 

• Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented.

• Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations

• The SPM, with support from the Project Management Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations.

What you will bring to the role

• High level of responsibility and accountability in all tasks.

• Communication skills.

• Ability to effectively perform in demanding situations.

• Thorough knowledge of project management processes with a solid understanding of how to craft and manage a project budge.

• Can demonstrate experience of successfully managing and/or leading multidisciplinary project teams.

Your experience

• 6-7 years' industry experience with a minimum of 5 years in a Clinical Project Management role, within a CRO setting.

• Oncology experience in a PM role is required.

• University/College degree, within Life Science is preferred.

• Ability to travel when needed

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

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 or connect with us on LinkedIn.

Originally posted on Himalayas

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

Essential functions of the job include but are not limited to:

• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed.
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Leads both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• Perform other duties as assigned by management
• Remain compliant with organizational training, time-reporting and any other administrative duties as required
• Provides on-going feedback, for functional team members including annual performance reviews

Qualifications:

Minimum Required:

• North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience
• Experience in managing complex and global trials
• Ability to travel domestically and internationally including overnight stays

Other Required:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS
• Proven communication and interpersonal skills to effectively interface with others in a team setting
• Proven organizational skills, attention to detail, and a customer service demeanor

Competencies:

• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Direct work experience in a global, cross-functional project management environment
• Good understanding of cross-functional management
• Good understanding of project planning, risk management and change management with an awareness of appropriate escalation
• Proven experience in strategic planning, risk management and change management
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Proven presentation, verbal and written communications skills
• Good understanding of project management software
• In depth proven experience in pharmaceutical and/or device research required
• Preferred: experience with oncology & cell and/or gene therapy

Originally posted on Himalayas