Clinical Project Manager, Clinical Adjudication

Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials?

Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research.

What we offer

Competitive compensation + shift allowances

Attractive benefits (security, flexibility, support and well-being)

Engaging employee programs

Technology for hybrid working and great onsite facilities

What you'll be doing

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

Oversees project close out by :

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 :

Communicating job expectations

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

What we look for

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

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

Clinical Adjudication experience a plus

Experience working with computer software including Word, Excel, Access and Project preferred

Strong interpersonal and communication skills, both verbal and written

Strong organizational and leadership skills

Goal oriented

Ability to maintain professional and positive attitude

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.