Senior Project Manager (APAC Region), Australia

The Senior Project Manager oversees and manages domestic, regional and/or international projects.

Indero 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.

Our Senior Project Manager 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. 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).

Senior Project Manager also acts as a mentor and provides training to other project managers and actively contributes to continuous improvement efforts of the department.

The Senior Project Manager may be requested to support additional tasks if deemed aligned with the objectives and department and/or company goals. These may include supporting the cross-functional departments to perform certain region or country-specific local administrative and/or business activities.

We are looking for someone who:

• Has at least 7 years of Global clinical project management experience (including but not limited to APAC regions), including management of all project’s phases from start-up to closure, management of all functional services, vendor management.
• Wishes to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects.
• Is looking to position themselves in an environment where you can grow your career alongside of a growing company.
  
  

Impact And Responsibilities

Client interactions

• Serve as primary contact for the Sponsor, vendors and internal team throughout the study.
• May serve as global project manager on multi-region projects.
• Manage key strategic clients and/or programs.
• Ensure assigned studies are “audit ready” at all times (project team training records, central files, system validation, etc.).
• Communicate effectively with sponsors, study team members, functional departments, and senior management
• Draft project operational plans, processes, and manuals as applicable (e.g., project management plan, risk management plan, etc .).
• Serve as escalation point for project issues to internal and external stakeholders, as appropriate. Proactively identify and resolve conflicts.
• May oversee vendors to ensure appropriate coordination and delivery of services, including risk identification and mitigation throughout the project.
  
  

Project planning

• Provide oversight of site and vendor budget tracking
• Proactively, manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Control 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
• Provide 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
• Define and manage project resource needs and establish succession plans for key team members.
  
  

Quality and risk management

• Lead 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.
• Manage risk and control measures to assure project quality. Escalate issue appropriately to Indero management, quality assurance and sponsor, when required.
• Lead 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.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables), address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the study team
• Analyze discrepancies between planned and actual results and participate in the development and implementation of corrective actions to be taken as needed.
• Ensure that project specific training matrix is customized to each study and maintained accurate through out the study
• Ensure all team members including contracted services providers have adequate training on the project by reviewing training records periodically during the trial
• Review and approve Indero, site, and vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Ensure 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
• Ensure 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
• Provide 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.
  
  

Project budget and timelines

• Manage and report on recruitment status and highlights initiatives needed to mitigate slippage in recruitment timelines
• Participate in the planning and conduct of Investigator’s Meeting.
• 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. Ensure that the Trial Master File (TMF) is complete, accurate, and inspection ready at all times.
• Support 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, ensure that the CRF complies with the protocol and Sponsor requirements and ensure queries resolution and data review process follow the study timelines until database lock.
  
  

Project team leadership

• Participate in mentorship programs to develop junior project managers or project managers new to the company.
• In collaboration with relevant departments, prepare and deliver presentations for new business as required
• May contribute to strategic development for new business opportunities.
• May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department
• May support in conducting Quality Assessment Visits of CRA within the region and/or country, where certain amount of travel is required
• May be delegated as system administrator to act on behalf of the company in completing local regulatory agency online platforms’ submissions
• May collaborate with cross-department business partners to provide region and/or country specific information and relevant industry updates
• May support to develop relationships with site staff, stakeholders and introduce KOLs in Indero’s main indication in dermatology (AD, HS, Pso, AA) and rheumatology (RA, OA, Scleroderma). Support in building and maintaining a network of interested sites
• May work with cross-department to support various start-up activities
  
  

Requirements:

Education

• B.Sc. in a related field of study to clinical research;
• At least 7 years industry experience and a minimum of 5 years in clinical trial project management with financial accountability.
  
  

Experience

• At least 7 years industry experience and a minimum of 5 years in 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 and/or rheumatology trials an asset
  
  

Knowledge And Skills

• 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;
• Excellent problem-solving , decision making, and strategic thinking abilities.
• Ability to work independently with no supervision.
• Exhibits exemplary leadership skills and serves as a role model.
• 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.

In this position, you will be eligible for the following perks:

• Flexible work schedule / work schedule :
• Home-based position
• Ongoing learning and development
  
  

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

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 Australia