Clinical Project Manager

SmartRecruiters, Inc.; Franklin (TN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Bioclinica seeks a Clinical Project Manager to drive study start-up through close-out, coordinating timelines, resources, and communications across study teams and sponsor representatives.

The role emphasizes project leadership within a CRO setting, with knowledge of GCP/ICH and FDA regulations, and collaboration across neuroscience, oncology, and other therapeutic areas.

Qualifikationen

• Bachelor's degree required or commensurate experience.
• 1-3 years clinical trials experience within a CRO or pharmaceutical research organization.
• Working knowledge of GCP, ICH guidelines and FDA regulations

Aufgaben

• Identifies project guidelines and communication needs with stakeholders.
• Defines project plans with timelines, milestones, and staff allocation.
• Establishes project reporting schedules and provides updates to leadership and sponsor reps.
• Coordinates site data collection with internal and external teams.
• Maintains SOP adherence and coordinates with QA for deviations.
• Provides team leadership, training, and performance feedback.

Kenntnisse

Project management

Leadership

Communication

Team coordination

Ausbildung

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft Project

Jobbeschreibung

Bioclinica is one of the leading global CROcompany which focuses on bringing efficiency to the clinical trials. We have a premier globalresearch network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We areheadquartered in Doylestown, PA.Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations

Job Description

The Clinical Project Manager will focus on study start up through close out activities and perform project analysis while highlighting leadership skills in therapeutic areas such as Neuroscience, Musculoskeletal, Oncology, Cardiovascular, and more. This individual would be driven, dedicated and adaptable in a fast-paced environment. Project Management experience within a CRO is highly desirable.

Primary Responsibilities

Identifies project guidelines and communication needs by:

• Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents
• Defining project plans (i.e. timelines, milestones and limitations for project staff)
• Establishing project reporting schedules
• Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule
• Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)

Performs project analysis and management by:

• Identifying critical project success factors for tracking, analysis and reporting
• Determining needed resources for project completion and communicating needs to appropriate departmental managers
• Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
• Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
• Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
• Understanding SOPs and working closely with QA for clarification and documentation of deviations
• Training and maintaining project team knowledge and applications of SOPs
• Communicating all protocol clarifications/revisions to project team
• Coordinating site management of data collection with internal and external teams

Provides project team leadership by:

• Leading by example with professional and collaborative conduct
• Developing and delivering team project training
• Establishing team performance expectations and guidelines
• Providing input to departmental managers of respective team members' performance level
• Analyzing team performance for consistency/quality within established project guidelines
• Collaborating with the departmental managers for team coaching/mentoring

Supports Business Development efforts by:

• Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
• Attending professional meeting(s) as Company representative
• Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services
• Assisting with coordination of submission activities, as applicable
• Assisting with initiating and overseeing all project close out activities to completion

Performs supervisory functions by, if applicable:

• Planning, monitoring and appraising job results
• Coaching, counseling and disciplining staff
• Initiating, coordinating and enforcing systems, policies and procedures
• Approving direct reports time sheets, requests for time off and/or overtime
• Performing timely performance evaluations of direct reports
• Coordinating and conducting new hire interviews; facilitating hiring decision
• Training new hires on departmental processes and responsibilities

Maintains Quality Service and Departmental Standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures("SOP")
• Establishing and enforcing departmental standards
• Reviewing and updating company SOPs related

Secondary Responsibilities

Contributes to team effort by:

• Exploring new opportunities to add value to organization and departmental processes
• Helping others to accomplish results
• Performing other duties as assigned and deemed necessary

Maintains Technical Knowledge by:

• Attending and participating in applicable company sponsored training

Qualifications

Education:

• Bachelor's degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable

Experience:

• Previous management or project experience in clinical development of investigational medications required
• 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role.
• Working knowledge of GCH, ICH guidelines and FDA regulations
• Medical Imaging experience a plus
• Experience working with computer software including Word, Excel, Access and Project preferred

Additional skill set:

• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain professional and positive attitude

Additional Information

Working conditions:

• Travel: 0-20%
• Lifting: 0-15lbs
• Other: Computer work for long periods of time

EEO Statement

Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic