Senior Project Manager
Note: despite the current context which affects recruitment for many organizations, this position is open and available.
Throughout this, our recruitment team remains dedicated to a quality candidate experience which may include interviews conducted via phone and / or video conferencing. Thank you for understanding.
The senior project manager 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 are proactively and effectively mitigated and client expectations are met.
The 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). The 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.
This role will be perfect for you if:
- You want to contribute your Phase III Global clinical trials experience to a growing specialized CRO focused towards the advancement of science and clinical research.
- You are a hands-on project manager. You are equally able to lead high-level project strategy and roll up your sleeves when needed to ensure the success of the project.
- Working with a truly collaborative team in a culture of learning and growth is appealing to you.
- Serves as primary contact for the Sponsor, 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 Innovaderm, 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 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. Ensures that the Trial Master File (TMF) is complete, accurate, and inspection ready at all times.
- May 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).
- 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.
- B.Sc. in a related field of study to clinical research.
- PMP certification is an asset.
- At least 15 years industry experience and a minimum of 10 years leading Phase III clinical trial projects (including financial accountability).
- Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD.
- 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, onco-dermatology, inflammatory bowel diseases, rheumatoid arthritis or oncology trials an asset.
Knowledge and 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.
The work environment
At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Senior Project Manager, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Benefits (medical, vacation, personal days)
- Ongoing learning and development
- Career opportunities within a growing company
This role may be based in Innovaderm’ s headquarters in Montreal, Canada or home-based (remote) in Canada or the United States. Candidates should have legal authorization to work in the country where they will be based.
Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 175 employees. 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, Innovaderm continues to grow and expand in North America.