The Programme Director will be responsible for the strategic oversight, delivery and governance of multiple clinical programmes across the company. The role requires hands-on leadership, strong client engagement and the ability to balance operational delivery with strategic planning. Key duties include defining programme scope, setting goals/milestones, managing budgets, leading teams, coordinating resources, mitigating risks and reporting progress to leadership. Our client is a relatively small team so this role is hands on managing studies, as well as leading strategy. A great and varied role!

Key Responsibilities:

· Strategy & Portfolio Leadership:

· Provide strategic oversight of multiple clinical programmes, defining and owning the end-to-end programme vision aligned with business strategy

· Translate strategic objectives into actionable, cross-functional delivery plans

· Ensure programmes meet sponsor objectives for timelines, budgets, quality, and compliance

· Monitor risks, dependencies and milestones, acting as the senior escalation point for complex issues

· Client & Stakeholder Management:

· Serve as the primary senior contact for assigned sponsors and partners

· Build and maintain strong, long-term client relationships based on trust, transparency and performance

· Lead or support sponsor meetings, steering committees and programme reviews

· Contribute to business development activities including bid defence meetings, proposals and scope development

· Operational Oversight:

· Provide leadership and guidance to Project Leads, Project Managers and cross-functional teams

· Ensure consistent application of SOPs, processes and best practices across all  programmes

· Support resourcing strategies, including capacity planning and prioritisation across studies

· Quality, Compliance & Risk Management:

· Ensure all programmes are conducted in compliance with ICH-GCP, regulatory requirements and internal quality standards

· Proactively identify quality and compliance risks and drive corrective and preventive actions

· Support audits and inspections, including sponsor and regulatory authority interactions

· People Leadership & Development

· Mentor and develop both junior and senior clinical operations staff

· Foster a collaborative, accountable and high-performance culture

· Support performance management, succession planning and talent development initiatives

· Budget and Resource Management:

· Plan programme budgets, monitor expenditure, and ensure financial resources are utilised within agreed limits

· Ensure all programmes are appropriately resourced, with staff, equipment and vendors available and used efficiently

Required Qualifications & Experience

· Bachelor's degree in Life Sciences or a related discipline (advanced degree preferred)

· Significant experience in clinical research within a CRO or pharmaceutical/biotech environment

· Proven experience leading multiple clinical programmes or large, complex clinical projects

· Strong understanding of clinical trial operations, regulatory requirements and quality systems

· Demonstrated success in senior sponsor-facing roles

· Strong strategic thinking combined with hands-on operational capability

· Excellent leadership, communication and influencing skills

· Commercial awareness, including budgeting, forecasting, and change management

· Ability to manage complexity, competing priorities, and ambiguity

· Strong problem-solving and decision-making skills

· Collaborative mindset with the confidence to challenge and escalate when necessary

· Appropriate working knowledge of GPP, GCP and the regulatory framework for clinical research

Candidates must be experts in clinical research and be able to work at our client's London office 3 days/ week. 

#ICHGCP #Clinicaltrials #ClinicalProject #haematology

Our client has an extensive global network of sites they work with to provide clinical trials to a range of sponsors and across various Therapeutic areas, although there is a focus on cardiovascular, haematology and oncology therapeutic areas. 
Ideally, we are seeking a CMP with a minimum of three years’ experience in the role — someone who can quickly adapt and provide effective support to the team in the background. Strong regulatory affairs experience (e.g., submissions) is essential.

Scope of Work

• Provide short-term project management support to an ongoing clinical study, ensuring delivery within agreed timelines, budgets, and quality standards, in full compliance with ICH-GCP, SOPs, and regulatory requirements.
• Oversee study operations and vendors, including CROs, sites, and external partners, maintaining effective communication, risk management, and documentation (e.g., TMF, contracts, budgets, and reports).
• Support the Clinical Operations team with coordination, issue resolution, and preparation of key study materials, contributing to process improvement and ensuring continuity during team absences.

Essential Experience:

• 5–10 years of overall clinical project management experience within a CRO or sponsor environment.
• Proven ability to manage timelines, vendors, and multi-site studies in accordance with ICH-GCP.
• Strong communication, organizational, and problem-solving skills; experience in cardiovascular studies preferred.
• Solid experience in regulatory affairs (submissions and documentation).
• Global experience managing complex interventional and observational studies.

#clinicalresearch #clinicaltrials #pharmajobs  #CROjobs #clinicalprojectmanager #clinicaldevelopment #londonjobs #clinicalstudymanagement #SCOPE2022 #decentralizedclinicaltrials #DCT #decentralizedtrials

Coronado Research is a consultancy-led, professional services organisation, which provides support to pharmaceutical, biotechnology, and medical device companies. As science changes, we are seeing the traditional clinical development model being replaced by a more targeted, precision-based approach. The introduction of new technologies, including tools leveraging Artificial Intelligence (AI) and Machine Learning, and novel methodologies is leading to a changed research paradigm. 

At Coronado Research, we are dedicated to advancing pharmaceutical research through cutting-edge clinical trials, providing expert-driven advice and support. We are creating developmental processes that match the latest science, looking at the end-to-end process, optimising the research continuum, and placing data at the centre. 

Role Overview 

We are seeking a proactive and resourceful Clinical Data Manager to support data management activities for a variety of different clinical development programs. This role is pivotal in ensuring the integrity, quality and timeliness of clinical trial data while maintaining compliance with industry regulations. The Clinical Data Manager will support all DM activities through trial set up, conduct and lock, working with cross-functional stakeholders to ensure seamless collaboration and data accuracy. 

Key Responsibilities 

• Data Management Study Participation: Conduct all clinical data management activities, including data collection, validation, cleaning, medical coding and reconciliation processes. 

   

• Data Management set-up: Contribute to the design, development, and review of Case Report Forms, Data Management and Data Review Plans and other study set up activities. 

   

• Data Validation & Quality Control: Take responsibility for the execution of data validation activities to ensure data consistency, accuracy, and completeness, EDC checks, data listings and other data review tools to ensure data integrity. 

   

• Vendor Data: Manage receipt and reconciliation of external data, ensuring deliverables meet quality, regulatory, and timeline expectations. 

   

• Issue Resolution & Support: Troubleshoot data-related issues and provide hands-on support to internal and external stakeholders. 

   

• Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, and programming teams to align data management activities with overall study objectives. 

   

• Documentation: Ensure that documentation required to demonstrate regulatory compliance are maintained accurately. 

   

• Regulatory Compliance: Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA). 

   

• Study Review & Reporting: Participate in data review meetings, contribute to database lock, and support clinical study report preparation. 

   

• Industry Best Practices: Stay up to date with emerging trends and best practices in clinical data management. 

   

Skills and Experience Required 

• Bachelor's degree in Life Sciences, Biotechnology, or a related field. 

   

• Proven experience in clinical data management within a biotech, pharmaceutical, or CRO environment. 

   

• Hands-on expertise with key clinical data management systems. 

   

• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and global clinical trial regulations. 

   

• Excellent logical, analytical and problem-solving skills with a creative and curious approach to help drive innovatio