Senior Project Manager, Early Phase and Translational Research (USA)

Senior Project Manager, Early Phase and Translational Research (Sr. PM, EPTR)



The Senior Project Manager, Early Phase and Translational Research (Sr. PM, EPTR) oversees and manages domestic, regional and/or international projects. The senior project manager is responsible for developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met. The Sr. PM, EPTR is expected to have a working knowledge of drug development and clinical trial execution. S/he has overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The Senior Project Manager acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline).

The Sr. PM, EPTR also acts as a mentor and provides training to other project managers and actively contributes to continuous improvement efforts of the department.

More specifically, the Senior Project Manager, EPTR must:

• Serves as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study.
• Ensures assigned studies are “audit ready” at all times (project team training records, central files, system validation, etc.).
• Communicates effectively with sponsors, study team members, functional departments, and senior management
• Serve as escalation point for project issues to internal and external stakeholders, as appropriate. Proactively identify and resolve conflicts.
• Proactively, manages operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinates tasks and deliverables from all functional departments involved in the project.
• Controls the project budget by ensuring that project team member understand the hours allocation for each task and review time billed to the study against the budget to control write-off and identify out of scope activities for change orders
• Provides efficient updates on trial progress to the internal and external stakeholders, with respect to site selection, vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract
• Defines and manages project resource needs and establish succession plans for key team members.
• Leads study start-up process, including but not limited to conduct of the Trial Kick-off meeting the set-up of trial master file (TMF), site selection and finalization of site lists, site activation, management of vendor set up timelines and site contracting and budgeting.
• Manages risk and control measures to assure project quality. Escalates issue appropriately to Innovaderm management, quality assurance and sponsor, when required.
• Leads client calls, internal work groups, vendor status update meetings. Ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
• Monitors the quality of study deliverables, (including vendor and SubCRO deliverables), addresses quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the study team
• Analyzes discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed.
• Ensures that project specific training matrix is customized to each study and maintained accurate through out the study
• Ensures all team members including contracted services providers have adequate training on the project by reviewing training records periodically during the trial
• Reviews and approves Indero, site, and vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Ensures that study specific documents and project deliverables (e.g., study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) are developed on time and meet study requirements
• Ensures all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Provides project status updates to external and internal stakeholders ensuring compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.
• Manages and reports on recruitment status and highlights initiatives needed to mitigate slippage in recruitment timelines
• Participates in the planning and conduct of Investigator’s Meetings
• Collaborate with the Regulatory Affairs group, to ensures submission to central are done on time and collection of required essential documents is complete prior to site initiation and maintained current throughout study duration. Ensures that the Trial Master File (TMF) is complete, accurate, and inspection ready at all times.
• Oversee clinical monitoring activities for site qualification, initiation, routine and close-out visits (i.e. project-specific training of CRAs, reviewing monitoring visit reports and follow-up letters, ensuring compliance with monitoring plan, escalation of site-related issues).
• Contributes to the development of the Clinical Monitoring Plan.
• Prepares and conducts project-specific training for the CRAs; may perform study initiation visits (SIV) for single-site studies.
• Develops the annotated site visit reports and monitoring tools such as source data verification worksheets.
• May serve as a point of contact for CRAs and Lead CRAs for assigned projects.
• Supports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.)
• In collaboration with the data management group, ensures that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock.
• Mentors team members.
• In collaboration with relevant departments, prepare and deliver presentations for new business as required
• May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements

IDEAL PROFILE

Education

• B.Sc. in a related field of study to clinical research;

Experience

• At least 7 years industry experience and a minimum of 5 years in Phase I-III clinical trial project management with financial accountability.
• Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD.
• PMP certification desirable
• Experience in one or more of the following considered an asset: cost management, study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management;
• Therapeutic experience managing dermatology trials an asset

Knowledge & skills

• Excellent knowledge of GCP and ICH standards, FDA and local country regulations;
• Excellent knowledge of Microsoft Office suite;
• Fluency in English with excellent oral and written skills, required
• Bilingualism (English and local language) is an asset
• Ability to work in a team environment and establish good relationships with colleagues and sponsors;
• Good problem-solving abilities;
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

About Indero

A Global Clinical Leader In Dermatology and Rheumatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in United States.