Project Manager (I, II, Senior)
Linical is a market-leading, midsized, global Contract Research Organization (CRO) with a significant footprint across North America, Europe and Asia-Pacific. With operations in more than 20 countries, Linical is a full-service drug development partner uniquely capable of conducting large-scale, multinational studies while delivering personalized, hands-on service. We are committed to providing clients with innovative, flexible solutions and expediting promising therapies for patients through the drug development lifecycle. We have an exciting opportunity to join our team as a Project Manager. We offer a unique working environment with a global team culture, competitive salary and benefits package.
The Project Manager is responsible for the overall management and oversight of assigned studies, including, but not limited to: developing project documents and deliverables; effectively communicating with the Client and study team; managing interdependencies across functional teams; training project staff; monitoring study progress to assess protocol adherence and to assure conduct meets quality, cost, and timeline deliverables; administering and providing oversight of study budgets; and managing third-party clinical vendors and contract staff.
Generally, PM I and PM II staff will be responsible for managing individual studies and assuring staff assigned to their studies are apprised of their responsibilities and performance, they will also be responsible for participating in process improvement initiatives. Senior PM staff will generally be responsible for managing larger, more complex studies/programs/global studies, mentoring PM I and PM II staff, contributing to department training initiatives, and providing expert clinical operations input into new business proposals and bid defense meetings.
- Ensures projects progress according to internal and Client quality standards to fulfill all federal and local regulations
- Develops, maintains, and communicates detailed project plans and timelines to study team members and management
- Oversees and tracks progress of project deliverables, including managing third-party vendors and/or contract staff
- Oversees the regulatory document collection and submission process. Ensures the Trial Master File is complete and audit ready.
- Reviews the study protocol, Case Report Forms, edit check specifications, and other project document deliverables for consistency within and across documents
- Assists in the identification, negotiation and contracting process with third-party clinical vendors
- Produces and distributes status and tracking reports to appropriate team members and senior management.
- Prepares for and attends Monthly Project Reviews.
- Maintains effective communication with the Client and project team through oral and written correspondence and project status reports; ensures adequate documentation of all communication
- Manages projects in accordance with the contract, proactively recognizing any changes in scope and collaborating with senior management to ensure timely completion of change orders
- Effectively manages project budgets to ensure financial targets are met through regular reviews of the study budget and expenses, and by collaborating with Finance to ensure accurate revenue recognition
- Projects staffing needs, and manages staff utilization by reviewing timesheet information at regular intervals
- Acts as the primary point of contact for Client interactions, establishing and maintaining a positive Client relationship throughout project conduct in order to help secure repeat business
- Prepares and presents project management capabilities in proposals workspace and at bid defense meetings
- Provides matrix management of assigned project staff with performance feedback delivered to Line Managers in a timely fashion.
- Ensures all necessary training is developed, delivered, and documented for assigned project staff
- Performs quality assessment visits as required
- Performs succession planning, and in the event of a team change, ensures a thorough and effective handover, documenting per SOPs
- Participates in process improvement initiatives as requested
- Other duties as assigned
- Bachelor's Degree in a scientific, healthcare, or related field; or equivalent combination of education and work experience
- Years and type of experience:
- PM I requires a minimum of four years of clinical research experience (e.g. Clinical Trial Manager, Clinical Research Associate) or equivalent
- PM II requires a minimum three years of project management experience, or other equivalent experience
- Senior PM requires a minimum of five years of project management experience
- Excellent working knowledge of ICH, GCP, and FDA guidelines/regulations
- Knowledgeable in all aspects of project management, and the drug development process, clinical trial conduct, including systems and procedures
- Excellent written and verbal communication skills, conflict management, time management, organizational, interpersonal, and problem-solving skills
- Strong team-building skills and the ability to work successfully in a matrixed team environment
- Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary
- Dedication to quality in all work tasks and deliverables
- Proficient in MS Project, Outlook, Word, PowerPoint and Excel products
Our employees enjoy a full range of comprehensive benefits to include but are not limited to medical, dental and vision insurance, company paid life insurance, paid holidays, PTO, 401K with employer match, long and short term disability, and long term career growth and development opportunities. If you have the experience required and are looking to join an energetic and collaborative team, please apply directly via our ADP portal.
Linical is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.