Lead CRA / Senior Clinical Site Manager

​

• Title: Lead CRA / Senior Clinical Site Manager

• Company: Single Sponsor / FSP (Embedded in top pharmaceutical company)

• Location: Remote in Sweden

• Salary: SEK65,000 – SEK72,000 per month plus car allowance (SEK4500 per month)

• Travel: approx. 50% (4-6 visits per month)

RBW Consulting are excited to announce an opportunity on behalf of one of our close clients. They are looking for an experienced Senior or Lead CRA to oversee studies and be the main point of contact for investigative sites throughout the study life cycle and be accountable for site start-up activities through to activation, as well as for study conduct through to close out. They are accountable for building and retaining investigator site relationships and providing support from site recommendation and throughout the lifecycle of studies. They will also be responsible for training junior/new CRAs in the group.

If you enjoy building relationships with sites and want the chance to step up into a site operations role with oversight responsibilities, this could be a great position for you. This is also a reduced travel position compared to traditional Senior CRA roles.

Key accountabilities:

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the company Clinical Team and key internal stake holders throughout the life cycle of UCB clinical trials

• Support company clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of company trials

• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of the company and its activities thereby increasing their desire to partner with the company

• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to company forums, boards and/or discussions

• Interact/train new investigators to work on company clinical trials

• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection

• Primary contact for sites regarding study-related issues.

• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.

• Interact/train new investigators to work on company clinical trials.

• Attend key therapeutic trainings/meetings and/or industry trainings.

• Support CPM in management of the study, including but not limited to:

• Vendor management

• Training

• Logistics

• Selection of sites

• Maintenance of study tracking

• Oversight of eTMF

• Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.

• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.

• Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.

• Prepare and/or review monitoring tools, e.g. monitoring manual

• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.

• Review and approval of site regulatory packages

• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.

• Contributes to updates of clincial program information, e.g., annual safety updates, Investigator’s Brochure, and on query resolution, as needed, etc.

• Depending on trial setting:

• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.

• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.

• Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

• Utilising all applicable Decentralised Clinical Trial (DCT) methods.

• Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with company innovation/Technology Transformation Implementation (TTI) Teams.

• Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.

• In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

Requirements:

• Candidates must speak both Swedish and Danish fluently

• Life science degree or equivalent

• At least 4+ years independent monitoring experience as a CRA in CRO or Pharmaceutical setting

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1273 049 215

Please click ‘apply’ or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.