Senior Project Manager-Oncology

4 weeks ago

Raleigh, United States Catalyst Clinical Research LLC Full time
Job DescriptionJob Description

As a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or management of a portfolio of functional projects, with minimal or no supervision. You will act as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget, according to the sponsor/CRO expectations and with the highest level of quality possible.

Position Qualification Requirements:

Education: University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology.

Experience:  7 years previous experience in a Project Manager role in a clinical research setting with a progression of increased responsibility over time. Experienced managing oncology projects- working in either cell therapy or CAR-T.

Required Skills: 

  • Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
  • Excellent written, oral communication and presentation skills.
  • Excellent interpersonal and organizational skills with demonstrated attention to detail.
  • Ability to read, write and speak fluent English.
  • Ability to build positive, productive client and team member relationships.
  • Demonstrated problem-solving capabilities, critical thinking, and analytical skills.
  • Good computer skills with good working knowledge of a range of computer applications.
  •  Ability to meet deadlines, multitasks, and prioritize based on project needs.
  • Ability to make sound decisions based on available information.
  • Ability to work both in a team and independently 
  • Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes
  • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%.

Position Responsibilities/Accountabilities:

  • Responsible for the overall coordination and management of clinical trials from start-up through close-out activities.
  • Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials.
  • Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training.
  • Direct all project staff across functional areas to facilitate study progress.
  • Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed.
  • Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed.
  • Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs.
  • Oversee negotiation, or may negotiate, of the site contracts and/or budgets as well as distribution of investigator grants. 
  • Oversee the supply of Investigational Product and other study materials to sites.
  • Work with sponsor to determine and implement patient retention strategies as needed.
  • Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues.
  • If part of the role, monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs.
  • Ensure project documentation is complete, current, stored appropriately and audit-ready.
  • Develop and maintain a close working relationship with sponsor study management team.
  • Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters.

Communication:

  • May serve as the primary liaison with the sponsor and project team for assigned studies.
  • Coordinate, plan and execute Investigator Meetings as needed.  May need support from a Senior Project Manager.
  • Lead internal project team meetings.
  • May lead sponsor project team meetings or collaborate with a Senior Project Manager.
  • Oversee the creation and distribution of study-specific newsletters as required.
  • Escalate issues and critical project matters in a timely manner to appropriate team members, senior management, and sponsor.

Powered by JazzHR

Y2e1NvYz6d

  • Senior Project Manager- Oncology

    3 months ago

    Raleigh, United States Catalyst Clinical Research LLC Full time

    Job DescriptionJob DescriptionAs a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or management of a portfolio of functional projects, with minimal or no supervision. You will act as the team leader, ensuring that assigned studies are delivered...

  • Senior Project Manager

    3 days ago

    Raleigh, North Carolina, United States Catalyst Clinical Research LLC Full time

    Job SummaryCatalyst Clinical Research LLC is seeking a highly skilled Senior Project Manager - Oncology to lead the coordination and management of clinical trials from start-up through close-out activities. The ideal candidate will have a strong background in project management, excellent communication skills, and the ability to work effectively in a team...

  • CapEx Regional Project Manager

    4 days ago

    Raleigh, United States Cogir Senior Living Full time

    THE COMPANYJoin our dynamic team at COGIR Management USA, a subsidiary of Canada's COGIR Real Estate. Specializing in modern aging management, we operate nearly 90 senior living communities across 11 states, encompassing over 8,000 units. Since our inception in 2018, we have seen robust growth through strategic acquisitions, including the notable Cadence...

  • Senior Project Engineer/Project Manager

    4 weeks ago

    Raleigh, United States Timmons Group Full time

    Timmons Group is currently accepting applications for experienced Senior Civil Project Engineer/ Project Manager candidates in our Raleigh Residential Land Development group. The Senior Civil Project Engineer/ Project Manager is responsible for deliv Project Engineer, Project Manager, Manager, Engineer, Project Management, Project, Construction, Business...

  • Senior Project Manager

    3 months ago

    Raleigh, United States Exyte Full time

    Your vision is ambitious . Just like ours. Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and...

  • Construction Senior Project Manager

    2 months ago

    Raleigh, North Carolina, United States gpac Full time

    Construction Senior Project ManagerOur client is a local commercial general contractor that has a great reputation in the area. They are seeking a Senior Project Manager to join their growing team immediately They are built on trust and integrity and specialize on ground up diverse commercial construction projects. They want qualified individuals that can...

  • Senior Vice President, Oncology Operations

    2 weeks ago

    Raleigh, North Carolina, United States Akumin Full time

    Position Overview:The Senior Vice President of Oncology Operations holds comprehensive P&L accountability and is tasked with achieving consistent year-over-year revenue enhancement and profitability within the designated Region.Key Responsibilities: This role encompasses strategic planning and execution, identification of acquisition opportunities, driving...

  • Senior Project Manager

    4 days ago

    Raleigh, North Carolina, United States Page Southerland Page, Inc Full time

    Position Summary We are seeking a Senior Project Manager dedicated to our Higher Education division. At Page Southerland Page, Inc., we are committed to design that enhances lives. We are looking for skilled individuals to join a collaborative and empowering work environment. Our firm offers architecture, engineering, interiors, and consulting services for...

  • Senior Project Manager, Construction

    4 weeks ago

    Raleigh, United States Chesapeake Contracting Group Full time

    Job DescriptionJob DescriptionThe Senior Project Manager develops, coordinates, implements, and manages all activities necessary to construct one of more projects safely, within schedule and budget, and to the quality specified. The Senior Project Manager is accountable for directing project teams, providing general administrative and technical leadership...

  • Senior Project Manager, Construction

    3 months ago

    Raleigh, United States Chesapeake Contracting Group Full time

    Job DescriptionJob DescriptionThe Senior Project Manager develops, coordinates, implements, and manages all activities necessary to construct one of more projects safely, within schedule and budget, and to the quality specified. The Senior Project Manager is accountable for directing project teams, providing general administrative and technical leadership...

  • Senior Civil Project Manager

    3 months ago

    Raleigh, United States Synerfac Full time

    Senior Civil Project Manager Summary We are seeking an experienced and highly skilled Senior Civil Project Engineer. The successful candidate will play a key role in leading and managing civil engineering projects from conception to completion. As a Senior Civil Project Engineer, you will be responsible for ensuring the successful delivery of projects,...

  • Senior Project Engineer/Project Manager

    1 month ago

    Raleigh, United States Timmons Group Full time

    Company DescriptionJob Description Timmons Group is currently accepting applications for experienced Senior Civil Project Engineer/Project Manager candidates in our Raleigh Residential Land Development group. The Senior Civil Project Engineer/Project Manager is responsible for delivering technically sound products to meet internal and external client...

  • Senior Project Engineer/Project Manager

    1 month ago

    Raleigh, United States Timmons Group Full time

    Job DescriptionJob DescriptionJob DescriptionTimmons Group is currently accepting applications for experienced Senior Civil Project Engineer/Project Manager candidates in our Raleigh Residential Land Development group.The Senior Civil Project Engineer/Project Manager is responsible for delivering technically sound products to meet internal and external...

  • Senior IT Project Manager

    2 weeks ago

    Raleigh, North Carolina, United States Focused HR Solutions Full time

    About the Role We are seeking a highly experienced Senior IT Project Manager to lead and deliver complex projects for our client based in Raleigh, NC. This is a full-time remote position requiring availability during EST business hours. Responsibilities: Oversee multiple complex IT projects simultaneously, ensuring successful completion within budget,...

  • Senior Scientist for Real-World Evidence in Oncology

    2 weeks ago

    Raleigh, North Carolina, United States Flatiron Health Full time

    Transform the Future of Cancer CareJoin a community dedicated to integrity and innovation, as we strive to enhance the oncology ecosystem. We are seeking a Senior Research Scientist to contribute to our mission of improving lives through insights gained from the experiences of cancer patients.Your RoleAs a key member of the Research Sciences (RS) department,...

  • Senior Project Manager

    1 day ago

    Raleigh, North Carolina, United States Focused HR Solutions Full time

    Job Details:This is a remote position that requires working in the EST time zone. The client is seeking a Senior Project Manager to lead a 12-month project with the option for extension. The project is located in Raleigh, NC.Key Responsibilities:Manage multiple large complex projects with a proven track record of delivering IT projects within budget, scope,...

  • Senior Project Manager

    3 weeks ago

    Raleigh, United States Redgate Full time

    Overview/ResponsibilitiesAs a Senior Project Manager based out of our Raleigh office, you will act as an Owner’s Representative to oversee the design and construction of a variety of large scale project types including pharmaceutical manufacturing, higher education and real estate investment trusts. The projects will be in various stages, including...

  • Civil Project Manager/Senior Project Manager

    2 weeks ago

    Raleigh, United States Timmons Group Full time

    Timmons Group is seeking a Civil Project Manager/ Senior Project Manager - Stormwater Management candidate to join our Stormwater Group located in our Raleigh, NC office location. Essential Duties and Responsibilities of a successful candidate includ Project Manager, Manager, Project, Management, Water, Civil, Construction

  • Senior Project Manager

    2 weeks ago

    Raleigh, United States U.S. Engineering Full time $111,920 - $158,087

    Job DescriptionJob DescriptionU.S. Engineering has been an industry leader since 1893. How? Constant innovation and a willingness to evolve. The construction industry changes rapidly, and we cultivate a dynamic workplace where even our newest team members can influence change and make an impact. We know that our most valuable asset is our people. Join...

  • Senior Construction Project Manager

    2 months ago

    Raleigh, United States Cooper Tacia General Contracting Company Full time

    Job DescriptionJob DescriptionPosition: Senior Construction Project Manager Description:Join Cooper Tacia General Contracting, a trailblazer in commercial and industrial construction. We're on the hunt for dynamic Senior Project Managers to spearhead our project execution team. As a Senior Project Manager, you'll lead our project teams closely...