Location: Spain - home based
Schedule: Full-Time, Permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Trial Manager to join one of our partner companies.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
- Support of the study feasibility of countries and locations. Ensure training of CRO field monitors on the protocol and key study elements along with CTL as needed to conduct feasibility and site selection and support site readiness for recruitment. Ensure that the training documentation is filed properly
- Approve CRO personnel responsible for overseeing or performing site management / monitoring activities
- Recognizing potential challenges within the protocol and operational aspects of the study, escalating to CTL if necessary, and developing appropriate measures with CTL Maintaining a solid understanding of the protocol in order to be able to answer standard questions from CRO field monitors and locations about the operation
- Review and approval of the study-specific model ICF, review and approval of the ICF country / location adjustments carried out by the CRO Review of site selection reports and recommendation of a list of sites for study participation to the Clinical Trial Team
- Develop and implement the study-specific Site Management Oversight Plan. Ensure that all essential documents are in place for site initiation approval and initial / subsequent IP release to the sites. Ensure that the CRO field monitors adhere to the monitoring plan. Communicate regularly with the CRO to ensure correct adherence to protocol, schedules and site procedures
- Main contact of the CRO for all potentially significant location-related quality / compliance problems and escalation to CTL and CTT as required
- Review surveillance visit reports to identify quality / compliance issues that require escalation to CTL and CTT and / or follow-up with the CRO field monitors for resolution with the sites
- Regular review of problems at the sites to identify trends for communication and take appropriate action with CTL and CTT. Classify the impact of the trends with CTL
- Monitoring of the country and location-specific TMFs maintained by the CRO; Documentation of sponsor supervision in the HQ-TMF and implementation of regular QC checks
Education and Experience:
- Bachelor's degree or equivalent qualification in the field of life science / healthcare. Master's degree is preferred
- Ideally experience in the pharmaceutical industry with strong experience in clinical research
- Experience in a monitoring role or a role overseeing clinical trials
- Work experience in a global team, team player
Specific Role Requirements and Skills:
- Fluent English (oral and written)
- Strong project management and leadership skills
- Ability to work under pressure
- Ability for innovative ideas and solutions
- Excellent negotiating skills
The Benefits of Working for TalentSource in Spain:
- Competitive Salary
- Health insurance
- Internet reimbursement
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- End of year party with the team
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Clinical Trial Manager, Clinical Trials, Clinical Research, Pharma, Pharmaceutical, Monitoring, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Clinical Trial Manager, Clinical Research Organisation, clinical trials, CRO, Monitoring, Pharma, Pharmaceutical