Lead Responsible Person (RP)

A dynamic, mid-sized CRO is looking for a Senior Clinical Research Associate to join its growing team. This is a home-based role with travel across the Midwest and West Coast.

Unlike metrics-driven environments, this company prioritizes quality over quantity, giving you the space to focus on delivering exceptional work.

 

Key Responsibilities

• Monitor Phase I–III oncology clinical trials on West Coast and Mid-West region. 
• Manage site activities: initiation, monitoring, and close-out visits.
• Ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
• Review source data and CRFs for accuracy and completeness.
• Act as main contact for sites and resolve issues promptly.
• Train site staff on protocol and study procedures.
• Prepare and submit monitoring reports on time.
• Travel as required to support assigned sites.

 

Candidate Profile

• Experience: Minimum 4 years of on-site monitoring as a CRA, with a strong track record in early phase research (Phase I-II). 
• Education: Bachelor’s degree (BSc, BA, or RN equivalent) in a life sciences or related field.
• In-depth knowledge of ICH-GCP and regulatory guidelines.
• Location: Must be based on the West Coast or in the Mid-West region, this is where all of the sites are

We’re partnering exclusively with a growing pharmaceutical company embarking on an exciting phase of site transformation and investment. Although a smaller facility, it forms part of a wider European network and continues to receive strong backing to expand its operations and modernise its infrastructure.

As the site prepares for the installation of new equipment and the enhancement of its operational capabilities, we’re seeking a motivated professional to join the Engineering team.

This position will take the lead on CQV activities, primarily focusing on commissioning and qualification. The ideal candidate will bring a flexible, hands-on approach – ready to contribute to key site projects in a collaborative, fast-evolving environment, and in compliance with GMP standards.

 

Requirements

• Pharmaceutical industry experience with an understanding of GMP
• Minimum 2 years’ engineering experience within a CQV capacity
• Knowledge and understanding of automation and computerised systems is a strong advantage
• Flexibility in being on site as required for additional work (overtime / TOIL available) as the site transforms

We’re working with a leading pharmaceutical company entering an exciting phase of growth, with new product introductions, operational scale-ups, and site expansions underway. This is a unique opportunity to join a small, hands-on site where you’ll play a key leadership role in shaping its engineering function. As Engineering Manager, you’ll take full accountability for a compact team, overseeing maintenance, servicing, and contributing directly to engineering projects. This is a varied, practical role ideal for someone who enjoys being close to the action and making a tangible impact day-to-day. You don’t need decades of experience – what matters most is your willingness to get stuck in and lead by example. Full training will be provided on pharmaceutical equipment and processes. Standard hours are 7am–3pm, Monday to Friday, but flexibility is essential due to occasional call-outs (including nights and weekends). Overtime/TOIL is available. Requirements: Minimum 2 years’ hands-on engineering/maintenance experience in a manufacturing environment Mechanical and electrical engineering capability preferred Supervisory experience is ideal, but strong technical depth and leadership potential will also be considered Pharmaceutical and/or GMP experience is a plus, but not essential Must live (or be willing to relocate) within one hour of the site due to call-out requirements

About the Role

We are seeking an experienced Programme Manager to lead and coordinate an accelerated development programme through CMC, preclinical, and IND-enabling phases. This is a unique opportunity to join a fast-moving biotech start-up in its build phase, driving execution across multiple CROs and workstreams.

The role is remote, requiring a highly flexible, hands-on approach and the ability to operate beyond rigid functional boundaries.

 

Key Responsibilities:

Programme Leadership:

• Maintain and drive the integrated development plan (CMC → PK → tox → IND).
• Own critical path, dependencies, risks, and mitigation strategies.
• Lead weekly operational cadence across internal teams and CROs.
• Adapt execution structure as the programme scales.

Vendor & CRO Management:

• Manage interactions with CROs across CMC, enzyme engineering, PK/PD, and in-vivo studies.
• Oversee SOWs, change orders, deliverables, budgets, and issue escalation.
• Ensure structured communication and alignment across all vendors.

CMC & Preclinical Coordination:

• Coordinate execution across analytics, linker/payload activities, formulation strategy, biodistribution, PK studies, and GLP tox planning.

Timeline, Budget & Documentation:

• Own Gantt charts, budget tracking, and deliverable logs.
• Ensure complete documentation and data-room organisation.
• Prepare operational materials for investors, advisors, and Board.

Regulatory Readiness:

• Coordinate packages and timelines supporting IND-enabling activities.
• Liaise with regulatory consultants to ensure programme alignment.

Build-Phase Flexibility:

• Operate effectively in a lean, high-intensity start-up environment.
• Contribute to establishing processes, templates, and operational cadence.
• Comfortable working outside narrow functional boundaries when needed.

 

Candidate Profile:

Essential Experience:

• 5+ years as a Programme/ Project Manager in biotech or CRO environments.
• Proven experience coordinating CMC and/or preclinical development programmes.
• Strong CRO/vendor management across multiple concurrent workstreams.
• Experience managing complex development timelines and budgets.
• Familiarity with biologics/ADC/large molecule workflows.

Desirable Experience:

• Exposure to ADCs or antibody-based therapeutics.
• Experience in early-stage or lean biotech settings.
• Contribution to IND-enabling packages.

Personal Attributes:

• Highly structured, delivery-focused, and operationally rigorous.
• Independent, proactive, and comfortable with ambiguity.
• Strong communicator with excellent organisational discipline.
• Thrives in a remote-first, high-accountability environment.

 

Ready to take ownership of a high-impact development programme and help bring first-in-class therapeutics to patients?
Apply now by sending your CV today!

RBW Consulting is thrilled to present an exciting opportunity on behalf of one of our esteemed clients. As one of the few rapidly growing Contract Research Organizations (CROs) for UK studies, our client is expanding their site management team with multiple hires this year. They are involved in a diverse range of studies, including cutting-edge research in advanced therapies such as CAR-T.

Join a highly experienced team dedicated to excellence in clinical research. In this role, you will benefit from a supportive management team committed to your professional growth. They provide clear guidance on the skills needed for advancement and offer fluid career development opportunities across various departments.

This company prioritizes quality over metrics and is currently generating significant excitement within their UK team.

 

Key accountabilities

• Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);
• Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;
• Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;
• Perform source document verification and case report form review;
• Perform regulatory document review;
• Conduct study drug inventory;
• Perform adverse event and serious adverse event reporting and follow-up; and
• Assess patient recruitment and retention.

Qualifications

• Bachelor of Science in health-related field (or equivalent)
• Proven CRA experience; 5 years minimum

 

Why Join?

• Supportive Environment: Build strong relationships with a transparent management team focused on your development.
• Innovative Approach: Work with a company that embraces a 360 monitoring approach and leverages AI to enhance efficiency and save time.
• Results-Driven KPIs: Our client's key performance indicators are centered around tangible study outcomes, such as patient recruitment, visit reports, and resolving site issues.
• Administrative Support: Dedicated admin staff to help with site management tasks, helping to maintain a balanced workload.
• Training: Extensive training and buddy system in place.
• Career Growth: promotion opportunities up to 4 times a year.
• Therapy Areas: Access to mixed therapy areas, including advanced therapies like CAR-T.

RBW Consulting is thrilled to present an exciting opportunity on behalf of one of our esteemed clients. As one of the few rapidly growing Contract Research Organizations (CROs) for UK studies, our client is expanding their site management team with multiple hires this year. They are involved in a diverse range of studies, including cutting-edge research in advanced therapies such as CAR-T.

Join a highly experienced team dedicated to excellence in clinical research. In this role, you will benefit from a supportive management team committed to your professional growth. They provide clear guidance on the skills needed for advancement and offer fluid career development opportunities across various departments.

This company prioritizes quality over metrics and is currently generating significant excitement within their UK team.

 

Key accountabilities

• Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);
• Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;
• Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;
• Perform source document verification and case report form review;
• Perform regulatory document review;
• Conduct study drug inventory;
• Perform adverse event and serious adverse event reporting and follow-up; and
• Assess patient recruitment and retention.

Qualifications

• Bachelor of Science in health-related field (or equivalent)
• Proven CRA experience; 3 years minimum

Why Join?

• Supportive Environment: Build strong relationships with a transparent management team focused on your development.
• Innovative Approach: Work with a company that embraces a 360 monitoring approach and leverages AI to enhance efficiency and save time.
• Results-Driven KPIs: Our client's key performance indicators are centered around tangible study outcomes, such as patient recruitment, visit reports, and resolving site issues.
• Administrative Support: Dedicated admin staff to help with site management tasks, helping to maintain a balanced workload.
• Training: Extensive training and buddy system in place.
• Career Growth: promotion opportunities up to 4 times a year.
• Therapy Areas: Access to mixed therapy areas, including advanced therapies like CAR-T.