Project Manager

4 weeks ago

Bangalore, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

Works independently to lead a project team or under the direction of a more senior Project Manager on a program of studies, while adhering to professional, SOP, regulatory and ICH/GCP standards. Assesses resource needs for project or program delivery based on scope of services to be provided. Manages and communicates scope of the project according to proposal, budget, timeline throughout the life cycle of the project. Works with project team on identification of work scope changes against the project timelines. Creates and/or review required project plans. Implement and monitor progress against project. Plans and timelines and revise as necessary. Ensure consistency of plans across programs. Organizes, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes, or delegates with oversight, the Project Log (Action/Decision/Issues) items to ensure appropriate project team member delegation and resolution. Performs overall management of the project timelines through use of MS Project ensuring that changes or updates are made and communicated in a timely manner. Renegotiates timelines with client and project team, as necessary. Develop a thorough understanding of clinical, biometrics and critical path activities. Proactively engages in both quality assurance and risk management and mitigation activities to ensure project deliverables are met according to both Fortrea and client requirements, ensuring appropriate escalation of risks to all stakeholders. Manages and communicates scope of the project according to proposals, budgets, and ongoing project progress. Works with project team in identifying, initiating work scope changes, tracking, and delivering to the client. Responsible for the review and assessment of ongoing hour/budget utilization throughout the course of project to ensure that the projects are meeting financial targets. Supports negotiations with client to ensure budget remains within contracted terms. Controls project margins and minimizes write offs by working with key stake holders and senior leadership. Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing, and performs client follow up as appropriate. Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client. May oversee timely uploading of documents by the project team into the TMF for client held systems. Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment. Accountable for developing Project Specific Training and ensuring project team members have read, reviewed, and documented project related documents and plans. Drives issue resolution at the project and program level. Ensures proper escalation of potential CQI per Fortrea SOPs. Contributes to audit responses from agencies and clients, as appropriate. Ensures lessons learned are implemented across projects currently being managed and across the department as applicable. Initiates and drives improvements to enhance the efficiency and the quality of the work performed on assigned projects. Assist in the reporting of strategic client metrics. Contributes to proposal strategy, development, and lead bid defense strategy for assigned business development opportunities. May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Managers. Increase potential for repeat business by establishing a strong working relationship with the client project team striving for client satisfaction and operational excellence.Site Management: Responsible for the oversight of site start up activities.Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Regulatory Submission, Greenlight.Assists in the design and maintenance of tools/ processes relevant to feasibility assessments and patient recruitment campaigns.Supervision of Investigator package review and approval prior to drug shipment.Supervision of study set-up with the clients regarding pre-study documentation for Investigator packages.Supervision of Site Budget and Statements of Agreement (SoA) documents that leads to an executed site contract.Supervision of Document Review, including Informed Consent Forms, Advertisements, labels, and protocols.All other duties as needed or assigned.

Qualifications (Minimum Required):

University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.

Experience (Minimum Required):

Minimum of 5 years’ relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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