PSI CRO

Title: Medical Monitor (Canada Board-Certified Gastroenterologist) Location: Remote, Canada Job Description: - Employees can work remotely - Full-time - Compensation: CAD 170,000 - CAD 185,000 - yearly Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Canada Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - Canada Board Certification in Gastroenterology required - Experience as a practicing Gastroenterology (minimum of 10 years) - Clinical Research experience preferred - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Additional Information As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Title: Proposal Manager Location: Mississauga, ON, Canada Job Description: Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 3,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. Job Description At PSI, Proposal Manager coordinates all phases of PSI’s proposal process while maintaining the company’s win rate of 30% and higher. You will contribute to everything from RFP strategy to bid defense slide decks. You will partner with global teams of subject matter experts from Feasibility, Medical Affairs, Project Management, Clinical Operations, Budgeting, and Business Development to rapidly produce winning proposals. This position is home-based This full proposal development cycle will include: - Preparing viable RFP calendars and ensuring RFP milestones are met by all involved individuals in a timely manner - Organizing, attending, and leading strategy calls for each RFP; preparing and distributing minutes/action items - Developing draft budgets: reviewing clients’ specifications, obtaining quality feedback from various stakeholders within the company - Working with the budgeting team to develop competitive budgets and obtaining missing costs - Preparing vendor RFPs and obtaining vendor quotes - Writing strategic proposals that meet our clients’ needs - Providing support for bid defense meetings - Maintaining all RFPs in Salesforce and PSI’s CTMS Qualifications - A minimum of a four-year degree from an accredited college or University - Experience managing full-service clinical trial proposals at a CRO - Writing and editing skills - Analytical skills - Time management and organization skills - Ability to manage multiple assignments under deadlines - Proven track record of proposal win rates - Flexibility and creativity in responding to potential clients - Proficiency in Microsoft Word, Excel and PowerPoint Additional Information This is a creative tight-knit team of professionals motivated by producing quality proposals that resonate with our customers. Our culture is open, collaborative, and purposeful. We’re now looking for talented people who don’t believe in one-size-fits-all templates and have a passion for writing proposals that get read and remembered.