Project Manager São Paulo – São Paulo – Brazil – Hybrid (Vila Olimpía) Who We Are
Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.
Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.
Basic Functions and Responsibilities includes, but are not limited to : ▪ Clinical Study Management: Manage clinical studies from study planning and set-up to study closure, following contract requirements.
▪ Budget and Timeline Management: Ownership and Oversight of the the budgets and timelines specified in the clinical study contract.
▪ Oversight of Functions: Provide oversight of other functions, including Clinical, Safety, Regulatory & Start-up, and Vendor Management.
▪ Business Development: Contribute to business development in the preparation of proposals (BIDs), and portfolio management activities.
▪ Customer Relationship: Act as the Intrials representative and primary point of contact with the Sponsor for the clinical study. Take ownership of the customer relationship throughout the project and drive the resolution of customer issues.
▪ Compliance: Ensure that study activities are conducted in compliance with Intrials quality standards, Intrials and/or Sponsor’s SOPs, GCP-ICH guidelines, and local and international regulations.
▪ Protocol and Training: Maintain an in-depth knowledge of the protocol, therapeutic area, and indication. Participate in study-related training to the Intrials clinical operations team involved in the study, offering regular support on various aspects such as protocol, monitoring plan, recruitment plan, CRF, monitoring tools, and study systems.
▪ Project Planning: Develop and review operational project plans in collaboration with the clinical study team. This includes Monitoring Plans, Communication Plans, Project Management Plans, Risk Management Plans, and others. Ensure that the study is executed in accordance with all established plans.
▪ Monitoring Quality: Ensure the overall quality of monitoring activities Identify and escalate significant issues reported by Clinical Research Associates (CRAs) and Clinical Trial Manager (CTM) to the Sponsor, and follows up until issue is resolved.
▪ Supplies and Materials: Take proper measures to ensure the adequate provisioning of supplies, devices, and materials required for the study, adhering to study specifications.
▪ Collaboration: Collaborate with other departments within the company to support milestone achievement and effectively manage study-related issues and obstacles.
▪ Advanced Risk Management: Identify, assess and develop mitigation strategies for risks in studies, together with the quality Department of Intrials
▪ Strategic Leadership: Lead the formulation and review of processes in collaboration with leaders from other functions, demonstrating leadership and strategic decision-making skills.
▪ Business Development: Actively participate in business proposals and portfolio development activities, including identifying new business opportunities and expanding relationships with existing sponsors.
▪ Complex Problem Solving: Managing and resolving study or client issues, requiring negotiation and conflict resolution skills.
▪ Additional Duties: The Project Manager may be assigned other duties to ensure completion of company objectives.
Primary Activities includes, but are not limited to:
▪ Regular communication with Sponsor in order to support the definition of the study design and the best strategy for project implementation in the countries covered by Intrials operations;
▪ Regular contact with other departments within the company to support milestone achievement and to manage study issues and obstacles;
▪ Establish an enthusiastic work environment and a motivated project team, encouraging open communication and ensuring high-quality work;
▪ Manage the feasibility process, supporting the approach, identification, and selection of sites to clinical study;
▪ Develop integrated study management plans with the core project team;
▪ Keep close contact with Sponsors / Investigators; ▪ Co-organize / conduct / participate in investigators meetings / other project related meetings (face-to-face or teleconference) according to Sponsor alignment;
▪ Organize / conduct meetings with Intrials study team at regular basis/whenever needed;
▪ Organize / conduct meetings with the Sponsor according to study project and Sponsor’s request;
▪ Provide support to CRAs, CTM and team at regular basis (protocol, monitoring plan, recruitment plan, CRF, monitoring tools, study systems, etc.);
▪ Assume and support monitoring activities whenever necessary;
▪ Oversee daily activities of operational team to ensure focus on quality and timelines;
▪ Ensure high quality level in data collection and queries resolution;
▪ Coordinate study activities with CRAs and CTM, including pre-selection visits, initiation visits, CRA training, recruitment, interim monitoring visits and close-out activities;
▪ Ensure study is conducted in compliance with all study plans;
▪ Ensure adequate provisioning of supplies, devices, and materials in the study, according to study requirements;
▪ Prepare / review study status tools (newsletters, recruitment status, periodic report, etc.) whenever needed or requested by the Sponsor;
▪ Identify and record non-conformity and provide preventive actions supported by Intrials QA department;
▪ Track study metrics and milestones to guarantee that the project is being conducted according to Sponsor’s requirements;
▪ Prepare / support contract and negotiate budget with study sites;
▪ Ensure study documentation is properly maintained and archived in e TMF / TMF and databases, as applicable;
▪ Ensure overall monitoring quality by reviewing and evaluating monitoring visits reports, detecting issues, resolving and/or escalating issues reported by CRAs;
▪ Manage risks and contingencies proactively and lead problem solving and resolution efforts;
▪ Mitigate risks with action plans in place as agreed with upper management and / or the Sponsor; ▪ Provide support to on-site audits and inspections;
▪ Review SOPs related to the department activities;
▪ Attend courses / meetings in order to improve / acquire new skills;
▪ Share lessons learned with the team and ensure adequate deployment of possible identified action plans;
▪ Prepare revenue reports own projects and revenue forecast.
Skills:
▪ University Degree (preferably in the health science area such as Pharmacy, Biology, Biomedicine, Nursing, Medicine, other);
▪ In depth understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates;
▪ Reliable and demonstrable professional experience;
▪ Good organizational, communication and interpersonal relationships;
▪ In-depth knowledge of ICH-GCP, national and international regulations;
▪ Training/presentation skills
▪ Fluency in English;
▪ Basic Spanish is highly recommended;
▪ Computer skills on Windows and Microsoft Office tools.