Simbec-Orion

Role Description We are looking for a Budget and Proposals Manager to join our Commercial team, where you will be responsible for managing the entire budget and proposal process, from the receipt of the RFP (Request for Proposal) to the timely delivery of documents. This includes ensuring that proposals include innovative solutions that accurately showcase Simbec-Orion's capabilities and that the budgets reflect the requested services. The deliverables for the budget include ballpark budgets and client grids, while the proposal deliverables can range from cover letters for RFIs (Requests for Information) and abbreviated proposal documents to complex proposals for international Phase III clinical studies. Additionally, the Budget and Proposal Manager coordinates strategy meetings with internal stakeholders, defines the scope and assumptions of RFP/RFI requests, attends regular meetings with clients and internal teams, and manages the development schedule and timeline for budgets and proposals. This ensures the successful, high-quality delivery of client-ready documents. Qualifications - Degree or equivalent qualification in life science, business or related field - Previous experience in Proposal Writing and Budget Development - Experience working in Clinical Research - English language skills – fluent in verbal, written and spoken - Attention to detail - Excellent knowledge of Microsoft Word, Excel and PowerPoint Requirements - Management of budgets, proposals and RFIs for clinical studies from content development to strategy lock and finalisation. - Ensure key strategies and selling messages are developed and clarified for proposals by utilising internal stakeholders' knowledge across the business. - Support the Business Development team with translating the proposed strategy and solutions mentioned in the proposal document into robust bid defence presentations. - Management of the process of obtaining vendor pricing for supporting services including vendor CDAs. - Creation of study budgets using appropriate costing tools to reflect both internal and client requirements, assuring accuracy, consistency, and competitiveness of budgets. - Facilitate pricing discussions and approvals with appropriately identified key decision-makers. - Negotiate internally with Heads of Department and Senior Management to achieve approval of client budgets and payment schedules. - Act as a point of contact for both internal and external customers for all tasks concerning budget development and payment schedules. - Support the commercial development and operations teams with the transition of awarded studies. - Support awarded projects and implement budgetary changes (change orders) as required. - Contribute to the development of departmental tools, systems and processes to improve efficiency and quality. - Ensure that bid data is accurately entered and managed within Simbec-Orion's CRM system (Salesforce) for future metric analysis. Company Description Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Role Description We are looking for a Sales Operations Analyst to join our Commercial team, where you will play a key role in strengthening the organisation’s commercial data, systems, and reporting processes. You will support the business development and marketing teams with lead generation and outreach activities, while ensuring data integrity, efficiency, and visibility of sales performance across the full sales cycle. You will be responsible for coordinating the maintenance and optimisation of commercial systems, including the CRM and reporting platforms, and for developing dashboards and analytical reports that track performance, forecast outcomes, and inform commercial decision-making. In addition, you will provide market intelligence insights using various databases, support pre-event outreach and meeting bookings, and build outreach cadences in Salesforce to drive targeted campaign activity. Key Accountabilities - Support the development and maintenance of the commercial data infrastructure, ensuring data integrity, consistency, and scalability across all sales and reporting systems. - Administer and optimise the CRM platform, managing data structures, automation, permissions, and workflows to maximise usability and maintain compliance. - Contribute to the design, build, and maintenance of analytics and visualisation tools to monitor pipeline, performance metrics, and forecasting accuracy. - Coordinate the development and automation of reporting frameworks, ensuring timely, high-quality commercial insights are delivered to the leadership team and other stakeholders. - Maintain forecasting models and dashboards that accurately represent opportunity status, conversion probabilities, and projected revenue at both account and regional levels. - Collaborate cross-functionally with Sales, Proposals, Finance, Marketing, Operations, and IT to ensure data integrity, alignment, and consistency across business systems. - Maintain and refine commercial processes, using data-driven insights to refine workflows, governance, and performance frameworks. - Develop and maintain Sales Tool Kits and related enablement resources, ensuring tools are current, effective, and aligned with commercial goals. - Act as the first point of contact for sales data, CRM, and reporting queries, coordinating with technical specialists and outsourced providers as needed. - Ensure compliance with data governance and reporting standards, maintaining consistent and auditable reporting outputs across the commercial function. Qualifications - Degree in Business, Data Analytics, Life Sciences, or a related discipline (or equivalent experience) - Experience supporting sales or commercial operations within a data-driven or business development environment - Working knowledge of CRM platforms (preferably Salesforce) and understanding of CRM data structures and workflows - Proficiency in Microsoft Excel and general data management tools - Good understanding of sales reporting, forecasting, and pipeline management principles - Strong organisational and coordination skills with attention to detail and accuracy - Effective communicator able to work across teams and translate reporting needs into technical requirements - Proactive and adaptable, with a willingness to learn and develop analytical and system administration skills Requirements - Experience working within a clinical research organisation (CRO) or other regulated industry - Exposure to Salesforce administration or configuration tasks - Familiarity with data visualisation tools such as Power BI or Tableau - Experience coordinating or supporting system or reporting projects with technical or outsourced teams - Understanding of data governance and compliance in a commercial context - Experience assisting with process improvement or change management initiatives Company Description Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity. The Role We are looking for a Senior Clinical Research Associate to join our Clinical Operations team where you will be responsible for the setup, monitoring, close out of sites, budget negotiations, and liaising with relevant authorities to ensure approvals are in place. Will be involved with more complex studies and challenging sites to monitor the progress of clinical trials onsite or remotely, to ensure the trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP. Will work closely with Clinical Trial Managers (CTMs), sponsors, project managers and other members of the study team to ensure study deliverables are met within the project timelines. Key Accountabilities - Contribute to site identification and feasibility activities. - Responsible for all aspects of study site management. (e.g. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc...). - Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File. - Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs. - Assesses IP accountability, dispensation, and compliance at the investigative sites. - Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs. - Collaborates with project functional leads as needed. - Attends internal and external project calls as requested and per budget to proactively provide required site updates. - Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC). - Facilitates site audits and audit finding resolutions. - May supervise work of, or mentor, less experienced CRAs, based on Mentoring program. - Serve as an observational visit leader. - Provide feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial. - Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes. - Can be involved in other tasks as assigned by Management, CTMs and PMs. - Escalate in timely manner any issue related to Quality or Data integrity. Skills Required Essential - Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required - Previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals - Good experience in CTMS, eTMF IXRS and EDC systems - Previous CRO experience - Excellent communication skills - Strong presentation skills - Proficiency in written and spoken English; fluent in host country language - Good knowledge of regional clinical research regulations and ICH-GCP - Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge - Ability to establish/maintain good relationships with sites/colleagues/clients - Ability to make decisions independently / Strong problem-solving skills - Highly developed mentoring and motivational skills Desirable - Advanced degree (Masters, MD, PhD) - Competent in clinical trial planning and metrics management About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity. The Role We are seeking an experienced clinical operations professional to take ownership of the planning, delivery, and oversight of clinical studies. In this role, you will lead the coordination of all Clinical Operations activities, ensuring studies are executed efficiently, to a high standard, and in line with agreed timelines, scope, and budget. You will oversee CRA and IHCRA activities, working closely with Project Management, Project Leads, and Sponsors to ensure seamless study delivery. As a subject matter expert, you will also play a key role in mentoring and developing colleagues, contributing to the continuous improvement of Clinical Operations across the organisation. Key Accountabilities - Responsible for management and oversight of CRA and IHCRA activity on the assigned study. - Responsible of preparation, maintenance, and execution of Clinical Operations plans. - Ensures study team receives study specific training according to Simbec Orion SOPs. - Ensures all clinical operation tasks are delivered on time and within agreed budget. - Communicates progress of clinical operation functions and assists project manager with tracking of project status. - Assists project manager with budgeting throughout the project and forecasting of clinical operations tasks within URF. - Contributes to regular updates to Clinical Trial Management Systems. - Attends and conducts project and internal calls as per budget to gather and deliver required clinical operation updates - Management of the identification, selection and activation process of study sites - Collaborates with cross-functional study team and study vendors as needed - Provide feedback to management on any current or potential risks or problems affecting the outcome of the clinical trial. - Escalate in timely manner any issue related to Quality, Patient Safety or Data integrity. - Produce accurate and timely visit reports in accordance with the monitoring plan and/or SOPs. - Conduct accompanied site visits with CRAs as required - Cover for CRAs working on the project, where necessary. - May supervise work of, or mentor, less experienced CTMs - Serves as a subject matter expert and works with Clinical Operation Managers (COMs) to provide departmental training and collaboration on SOP/WI and departmental templates and processes. Skills Required ESSENTIAL - Bachelor’s degree in Nursing, Life Sciences or Medical Sciences - or equivalent work experience required - Experience as a PM, CTM or equivalent role - Competent in clinical trial planning and metrics management - Excellent communication & presentation skills - Proficiency in written and spoken English; fluent in host country language - Expert knowledge of relevant clinical research regulations and ICH-GCP - Ability to establish/maintain good relationships with sites/colleagues/clients - Ability to make decisions independently / Strong problem-solving skills - Highly developed mentoring and motivational skills - Good working knowledge of applications and Systems (e.g., CTMS, eTMF, IVRS/IWRS and EDC). DESIRABLE - Previous CRO experience - Multiple therapeutic experience, preferably oncology, and proven ability to gain in-depth protocol knowledge - Experience in study Start-up, budgeting and forecasting About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity. The Role We are seeking a Medical Director to join our Clinical Development team, providing senior medical oversight for complex clinical studies conducted by Simbec-Orion. You will be responsible for ensuring scientific integrity, patient safety, and regulatory compliance throughout the study lifecycle, while acting as Medical Monitor for assigned trials and delivering expert clinical interpretation and safety leadership. You will work cross-functionally with teams including Clinical Operations, Project Management, Pharmacovigilance, Biometrics, Regulatory, Technical Writing, and Business Development to support high-quality study delivery and consistent medical standards across the organisation. In addition, you will contribute strategic medical expertise to proposals, feasibility assessments, and study design, and represent the medical function in client discussions and bid defence meetings, clearly articulating clinical strategy and safety oversight to support successful business development outcomes. Key Accountabilities - Act as Medical Monitor for assigned clinical trials, providing independent medical oversight throughout the study lifecycle. - Serve as the primary escalation point for internal and external stakeholders for all medical and safety issues within assigned studies. - Ensure clinical trials are conducted in compliance with applicable regulations, guidelines, and ethical standards. - Collaborate cross-functionally to support successful study delivery and maintain high levels of client satisfaction. - Oversee the preparation and review of medical and patient narratives and safety update reports to ensure accuracy, quality, and regulatory compliance. - Ensure departmental SOPs are reviewed regularly and updated in line with current regulations, guidelines, and industry best practice. - Contribute to all stages of clinical trial development, including feasibility assessment, protocol and case report form design, investigational site selection, medical monitoring plan development, ongoing medical oversight, adverse event and serious adverse event management, and participation in study-related meetings. - Support business development activities, including proposals, feasibility assessments, site engagement, and bid defence meetings. - Provide therapeutic area expertise across the organisation, including delivery of internal training and review of study protocols and bid proposals. - Lead the resolution of departmental CAPAs and escalations, and cascade relevant audit findings to study teams to ensure appropriate corrective and preventive action. - Ensure timely and comprehensive responses to audit findings and regulatory queries relating to medical and safety matters. - Maintain up-to-date knowledge of developments in therapeutic areas, regulatory requirements, and medical practice relevant to company projects. - Develop and maintain relationships with Key Opinion Leaders and investigators to support study design, patient safety assessment, and business development activities. - Support the Pharmacovigilance function through medical review of ICSRs, CIOMS narratives, and periodic safety reports, identifying and communicating emerging safety trends to project teams and clients. - Provide effective line management to assigned team members, including performance management, objective setting, resource planning, professional development, and ensuring delivery of high-quality work aligned with regulatory, organisational, and study requirements. Skills Required ESSENTIAL - Medical degree with specialisation in Oncology (or equivalent clinical experience in oncology) - Substantial experience as a Medical Monitor within a clinical research environment, with a focus on oncology studies and patient safety oversight - Extensive experience in clinical trial medical oversight within oncology, including adverse event and serious adverse event management, safety signal evaluation, and regulatory compliance - Experience supporting regulatory inspections and audits, including CAPA development and management - Demonstrable involvement in business development activities, including feasibility assessments, protocol input, proposal development, and bid defence participation within oncology trials - Strong commercial awareness, including understanding of clinical trial budgeting and financial drivers within a CRO environment - Strong written and verbal communication skills, with the ability to translate complex oncology data into clear insights for clients and cross-functional teams - Proficiency in electronic data capture systems, safety databases, and Microsoft Office applications DESIRABLE - GMC registered with a licence to practise (or equivalent international registration) with oncology specialism - Pharmacovigilance experience within oncology, including medical review of ICSRs and periodic safety reports - Experience working within a CRO, biotechnology, or pharmaceutical environment with a focus on oncology drug development - Previous experience leading a medical and/or safety function, including direct line management responsibility About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity. The Role We are looking for an Associate Medical Director to join our Medical - Clinical Development team, where you will assume medical responsibility for clinical studies conducted by Simbec-Orion and is responsible for the clinical interpretation of data and to ensure clinical trials are conducted such that subjects' rights, safety and wellbeing are protected and that the clinical trial data are reliable. Assists in cross-departmental medical monitoring activities and works with the wider cross-functional team that include Clinical Operations, Project Management, Pharmacovigilance, Business Development, Biometrics and Regulatory and Technical Writing. Key Accountabilities - Acts as Medical Monitor for more complex trials. - Participates in all stages of the Clinical Trial Development process, e.g., feasibility assessments, protocol design, case report form design, investigational site selection, medical monitoring plan development, ongoing medical support, management of AE's and SAE's, and involvement in trial-related meetings. - Responds to study specific audit queries and supports in the resolution of the audit findings. - Supports the Medical Director in resolving general department CAPAs, escalations and cascading any audit findings to the study team during monthly department meetings. - Generation of protocol and synopsis writing with sponsor and Technical Writing team. - Review Clinical Study report and provides feedback to the Medical and Technical Writing team. - Generates Medical and Patient narratives and safety update reports. - Provide therapeutic area support throughout the organisation, including the provision of required internal training and review of study/bid proposals. - Maintain knowledge of trends and changes of importance in the medical management of indications, regulations and guidelines relevant to Simbec-Orion's projects. - Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to Simbec-Orion as a resource of specific information on indications, patient treatment, and safety assessment for ongoing studies and support business development activities. - Supports the Pharmacovigilance department in reviewing ICSRs, CIOMS narratives, and periodic safety reports and identifies and communicates emergent safety aspects and trends to the Clinical Project Teams and client. - Ensures that Clinical Trials conducted by Simbec-Orion meet the relevant regulations and guidelines and are conducted to the highest ethical standards. - Supports the development of Standard Operating Procedures to drive best practice across the Medical Department. - Interprets Clinical and Pharmacovigilance data (including the coding of clinical data and the review of relevant safety reports) to identify any potential safety concerns and advise the study team accordingly. - Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings. - Supports the study team in reviewing audit findings that require medical input and communicates to the Head of the Department to apply corrective and preventive actions. Skills Required ESSENTIAL - Medical Degree - Background in Dermatology or Neurology, with demonstrable clinical experience in one of these therapeutic areas - Experience in medical monitoring, review of patient, laboratory, and safety within a clinical research environment - Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings - Excellent organisation and time management skills. Ability to effectively manage any changes to priorities/deadlines - Experience in Regulatory and sponsor audit and resolving CAPAs. - Experience in Pharmacovigilance process, including medical review. - Professional communication and presentation skills - Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as Excel and Word DESIRABLE - GMC Registered with a License to Practice - Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine - Previous experience of working within a small/mid-size CRO, biotech or pharmaceutical company - Proven experience in building effective relationships with external clients and sponsors About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Our Mission Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity. The Role We are looking for a Medical Director to join our Medical - Clinical Development team, where you will lead and manage the Medical Department, ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical Studies conducted by Simbec-Orion and will provide interpretation of clinical data. You will work collaboratively with cross-departmental medical monitoring activities (e.g. clinical operations, project management, pharmacovigilance, business development, biometrics, regulatory and technical writing) to drive best practice across the organisation. Key Accountabilities - Leads and manages the Medical Department, reviewing the department's quality of medical tasks, ensuring that standard operating procedures are followed. - Serves as point of contact for both internal and external stakeholders for issue escalation of any medical and safety issue in the study. - Ensure that departmental SOP's are reviewed on a regular basis to ensure they comply with the latest changes in regulations and guidelines. - Acts as Medical Monitor for assigned trials. - Participates in all stages of the Clinical Trial Development process, e.g., feasibility assessments, protocol design, case report form design, investigational site selection, medical monitoring plan development, ongoing medical support, management of AE's and SAE's, and involvement in trial-related meetings. - Ensures audit queries are responded to. - Ensures Medical and Patient narratives and safety update reports are generated. - Resolve general department CAPAs, escalations and cascade any audit findings to the study team during monthly department meetings. - Provide therapeutic area support throughout the organisation, including the provision of required internal training and review of study/bid proposals. - Maintain knowledge of trends and changes of importance in the medical management of indications, regulations and guidelines relevant to Simbec-Orion's projects. - Develops interactions with Key Opinion Leaders and investigators in therapeutic areas of interest to Simbec-Orion as a resource of specific information on indications, patient treatment, and safety assessment for ongoing studies and support business development activities. - Supports the Pharmacovigilance department in reviewing ICSRs, CIOMS narratives, and periodic safety reports and identifies and communicates emergent safety aspects and trends to the Clinical Project Teams and client. - Ensures that Clinical Trials conducted by Simbec-Orion meet the relevant regulations and guidelines and are conducted to the highest ethical standards. - Supports in business development activities, e,g, proposal requests, feasibility and site contact, and attendance at bid defence meetings. - Liaise with other functions in order to ensure client satisfaction through successful execution of clinical projects. - Review annual departmental budget and provide continuous oversight/control. Skills Required ESSENTIAL - Medical Degree - Background in Dermatology or Neurology, with demonstrable clinical experience in one of these therapeutic areas - Experience in medical monitoring, review of patient, laboratory, and safety within a clinical research environment - Previous experience of leading a Medical and/or Safety Department - Significant experience in audits and CAPA management - Significant experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings - Understanding of financial project management, including departmental budget oversight and revenue recognition - Professional communication and presentation skills - Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as Excel and Word DESIRABLE - GMC Registered with a License to Practice - Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine - Pharmacovigilance experience - Experience working in a CRO, biotech or pharmaceutical company About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.