Immediate opening for a Project Manager with Late Phase experience for our Raleigh, NC or other US office location.
INC Research, a global clinical research organization, is seeking an experienced clinical research professional for a US-based project manager position to support our Post Approval research team. This position ensures the contracted services and expectations of a clinical study are carried out by the INC Research (INCR) project team in accordance to the executed contract and the Customerís expectations. Works in the role of a project manager on assigned project(s), which may range from single service studies to full scope or multiple protocol projects. Duties include primary liaison with Customers, Vendors and/or Investigative Sites. May have line management responsibility for project management staff.
Job responsibilities include:
1. Acts as a primary liaison between INCR and the Customer to ensure study launch, conduct and closeout according to the Customerís and INCRís contractual agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
2. Serves as the team leader by overseeing the project team including the clinical team. Acts as a liaison and facilitator between other operation departments within INCR for project related tasks and/or issues. Plans and projects resources required across all areas of the study. Manages projects ranging in size and complexity from single service studies to full scope or multiple protocol projects with interaction from supervisor.
3. Actively manages and mentors other Project Management staff (which may include junior level project management staff) in general team leadership skills, project management skills, internal INCR processes and for project specific tasks.
4. Manages the executed contract and financial aspects of assigned projects. Reviews study budgets and expenses and ensures all study related contractual and budgeting issues are upheld and performed. Oversees and tracks site payment issues as required. Alerts Finance on the need for customer invoicing.
5. Develops knowledge of current therapeutic environment and drug development trends. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.
6. Reviews protocol and draft case report forms (CRFs) for consistency within each document. Develops and maintains project plans for the study in accordance with INCR SOPs and work instructions.
7. Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication
8. Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing and tracking reports, and functional area plan, to appropriate team members and senior management.
9. Performs on-going review of project financial status of studies within his/her responsibility. Alerts senior management to potential issues and ensures necessary corrective action is taken.
10. Independently prepares information for internal review meetings. Presents prepared information at project review meetings.
11. Oversees the regulatory document collection and submission process.
12. Networks to acquire new and/or repeat business.
13. Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, drug packaging, labeling and storage, and Interactive Voice Response System companies.
14. Supports the Business Development Department by providing information on INCR capabilities, patient populations, etc. Presents company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
1. May perform or oversee site feasibility assessments.
2. May participate in proposal and investigator grant determination.
3. May participate in Customer proposal development.
4. May represent INCR at professional meetings or seminars.
5. Performs other work-related duties as assigned.
6. Minimal travel may be required (up to 25%).
Requires a B.A./B.S. in the life sciences, nursing degree, or equivalent, plus moderate clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. CRO and relevant therapeutic experience is preferred. Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary. Must have demonstrated proficiency with ICH/GCP guidelines. Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment are essential. Requires presentation, documentation and interpersonal skills as well as a team-oriented approach. Proficient computer skills in Word, Excel, PowerPoint, Email and Internet are necessary; basic computer skills using MS Project are required.
Requires 3 years of related experience.
At INC Research, It's ""All About the Process""
For more than two decades, INC Research has been a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric trials. Our Trusted Processô methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina, and has a presence in 40 locations worldwide.
INC Research is pleased to offer our employees a comprehensive benefits plan that includes: Healthcare Coverage (Medical/Dental/Vision), Flexible Spending Accounts, 401(k), Life Insurance and AD&D, Short- and Long-Term Disability, Supplemental Income Protection, Employee Assistance Program, Paid Time Off and Paid Holidays.
How To Apply
Please complete or update your profile using our online career site (iRecruitment) to apply and be considered for this opportunity.
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