Novotech Global

Role Description Novotech is seeking an experienced Project Manager to lead the successful delivery of global clinical trials from study start-up through close-out. As the primary point of contact for sponsors, you will oversee project planning, execution, financial management, and cross-functional collaboration to ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, applicable regulations, and Novotech SOPs. This role requires a proactive leader with strong stakeholder management skills, commercial awareness, and the ability to manage multiple priorities while driving operational excellence. Key Responsibilities - Project Leadership - Lead the end-to-end delivery of clinical studies from feasibility and site selection through study close-out. - Develop and maintain project plans, timelines, risk registers, and study tracking tools. - Coordinate cross-functional teams, including Clinical Operations, Regulatory Affairs, Biometrics, Medical, Pharmacovigilance, and Vendor Management. - Identify project risks and implement mitigation strategies to ensure successful study delivery. - Ensure projects are conducted in accordance with study protocols, ICH-GCP, local regulations, and company SOPs. - Client & Stakeholder Management - Serve as the primary point of contact for sponsors throughout the project lifecycle. - Build strong client relationships through regular communication, project updates, and proactive issue resolution. - Lead project meetings, governance calls, and contribute to bid defence meetings where required. - Collaborate with Business Development during feasibility assessments and change order activities. - Financial & Operational Management - Manage project budgets, revenue forecasts, profitability, and financial performance. - Monitor project scope and coordinate change orders as required. - Ensure appropriate project resourcing and support effective workload planning. - Oversee vendor selection and management to ensure quality delivery. - Site & Study Management - Oversee site selection, activation, recruitment, monitoring, and study close-out activities. - Support ethics and regulatory submissions in collaboration with Clinical Operations and Regulatory teams. - Monitor recruitment performance and implement strategies to improve enrolment and site performance. - Ensure inspection and audit readiness throughout the study lifecycle. - Leadership & Continuous Improvement - Lead, mentor, and support cross-functional project teams, including Associate Project Managers. - Foster collaboration, accountability, and high-performance project execution. - Contribute to process improvements, SOP development, and operational excellence initiatives. - Represent Novotech professionally with sponsors, investigators, and industry stakeholders. Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline. - Significant experience in clinical project management within a CRO, pharmaceutical, or biotechnology environment. - Strong understanding of the clinical trial lifecycle, including study start-up, site management, recruitment, data management, and study close-out. - Comprehensive knowledge of ICH-GCP, global clinical trial regulations, and sponsor requirements. - Proven experience managing cross-functional global clinical teams, budgets, timelines, and project risks. - Strong client-facing experience with the ability to build trusted sponsor relationships. - Experience with CTMS, eTMF, Microsoft Office, and other clinical trial management systems. - Excellent communication, negotiation, and stakeholder management skills. Benefits - Collaborative culture and opportunities for career growth. - Access to mentorship opportunities and professional development programs. - Flexible benefits framework to empower work-life balance. - Dynamic community that supports personal growth and professional satisfaction.

Brief Position Description: The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs. Minimum Qualifications & Experience: - Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous. - Entry to less than 2 years’ experience as inhouse CRA or relevant roles. Responsibilities: - Support the clinical team’s inhouse activities on assigned projects. - Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs. - Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs. - Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data. - Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA. - May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits. - May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase. - May assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. Prepare and amend the CTA within agreed negotiation parameters and policies. Work closely with the Project Management, Clinical Operations and Legal teams to facilitate timely execution of CTA. - Prepare and update site Subject Visit Template (SVT)’s in accordance with site budgets. - Take a responsibility of submission and tracking of Investigator payments in CTMS and any finance system. Complete study finance reconciliation as requested by the CRA, ensuring subjects activities are updated. - Assist with vendor management updates, tracking and payments as requested by the CRA including updating laboratory normal reference ranges. As required also support sourcing supplies, shipment arrangement and customs clearance. - As required, may contact site staff/Investigators on behalf of the CRA to request information or resolve issues. - Take responsibility of document archiving as per Novotech SOPs. - Where required, track and report study SUSARs/CIOMS to the relevant stakeholders, i.e., Regulatory Authorities, Investigators and Sponsors according to the Safety Management Plan and Clinical Monitoring Plan. - Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. - Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. - Be aware of and adhere to company processes in areas relevant to an Inhouse Clinical Research Associate. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. - Strategic vs transactional mindset. - Ability to gain insights and make proactive decisions quickly. - Culture that fosters partnership and collaboration, where every voice is heard and valued. - Ongoing support from senior stakeholders and leadership team. .

Brief Position Description: The Associate Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client’s expectations. Minimum Qualifications & Experience: - Graduate in a clinical, pharmacy or life sciences related field. - At least 3 years’ experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations. - Through knowledge of applicable regulations. - Able to manage in a matrix environment. - Confident decision-making and problem-solving. - Competent working in virtual teams across time zones. - Strong presentation, documentation, and people skills. High proficiency in English. Responsibilities: - Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan. - Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy. - Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan. - Distribute start up related documents to local regulatory start up teams. - Proactively identify any risks to start up and escalate to Project Manager. ✓ Oversee customization of core start-up documents to local requirements. ✓ Ensure preparation and distribution of core contract and budget templates to applicable team members. ✓ Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines. ✓ Oversee site activation package compilation and approvals. - Develop RSU mitigation plans. - Provide timely update of regulatory start up progress to Project Manager. - Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings. - Serve as a client’s contact for regulatory start up related items. - Support business development by providing relevant information on regulatory start-up and attending Bid Defenses to present Novotech’ s regional capabilities. - Ensure accurate completion and maintenance of internal systems including - Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start up activities. - Facilitate cooperation between cross-functional teams. - Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence. - Identify areas of inefficiency in regulatory start up process and make recommendation for improvements. - Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings). - Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. CTMS, relevant databases, and tracking tools. Associate Regulatory Start-Up Manager (ARSM) This role is for individuals who are new to the role of Project Manager or Regulatory Operations Manager or other leadership role within the CRO industry. - Essential training in the areas of customer service, project management skills and regulatory and start-up technical skills will be provided at commencement of the position. Responsibilities: - Works with assistance from Line Manager and guidance from functional mentor to deliver start-up of projects as outlined in the core responsibilities of this document. - Primarily manages single country or small sized projects. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. - Strategic vs transactional mindset. - Ability to gain insights and make proactive decisions quickly. - Culture that fosters partnership and collaboration, where every voice is heard and valued. - Ongoing support from senior stakeholders and leadership team. .

About the Role The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. Responsibilities - CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. - Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines. - In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed. - In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. - Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required. - Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP. - Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly. - Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan. - Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol. Experience and Qualifications - Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. - Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. - Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows: - At least 2-3 years of Clinical Research Associate experience in the Clinical industry. - Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech. Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. - Strategic vs transactional mindset. - Ability to gain insights and make proactive decisions quickly. - Culture that fosters partnership and collaboration, where every voice is heard and valued. - Ongoing support from senior stakeholders and leadership team. .