Covance Clinical Research Manager - Sponsor Dedicated (office based) in Madrid, Spain
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Clinical Development team in Madrid and are currently seeking to hire a Clinical Research Manager .
This is a permanent, full time position, based in our Sponsor's Madrid office.
This role will be accountable for the end to end (from feasibility to close out) performance and execution of the clinical trials for assigned protocols, under the oversight of the country TA Director. The role should be responsible for 4 to 10 clinical trials and will ensure excellent study performance with strict adherence to local regulations, company SOPs and ICH GCP.
The role will work at country level with other local stakeholder like GMA, GHH, PV and regulatory to ensure alignment and development of the country capabilities in collaboration with the TA director and/ or CRD.
Responsibilities include, but are not limited to:
Accountable for the successful execution, enrollment and quality of their clinical trials
Accountable to ensure timelines and key milestones are met in assigned clinical trials
POC for assigned protocols between CO and ROC or/and HQ team .
Collaborates with TA director, CRA manger and other local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites
Responsible for quality and compliance in assigned protocols in country. Oversees CRAs in collaboration with CRA manager. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
Collaborates and works closely with other stakeholders in the assigned protocols in GCTO & GCD regional and headquarter teams, quality, finance and IT.
Collaborates externally with investigators, regulators and vendors
Supports strategic initiatives across Global Clinical Development GCD and GCTO
Supports local strategy development consistent with long-term corporate needs in conjunction with TA director and CRD.
The opportunity to work within an experienced and highly skilled team.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
KEY WORDS: clinical research, pharma, clinical trials, clinical research associate, clinical team lead, clinical project lead, Madrid, sponsor based
Education / Qualifications
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
Thorough understanding of the drug development process.
Working knowledge of Covance SOPs.
Experience as a Senior Clinical Research Associate, whether internal or external.
Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of:
Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
Site monitoring and study site management requirements;
Applicable regional regulatory requirements;
Trip report review, risk planning, study plan development, resource planning and data management oversight.
In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
Additional requirements include:
Demonstrated ability to work with minimal supervision.
Demonstrated good planning and organization skills.
Good computer skills with good working knowledge of a range of computer packages.
Demonstrated effective and professional verbal and written communication skills.
Ability to train, lead and develop junior staff.
Ability to understand and work with financial information.
Ability to resolve project-related problems and prioritizes workload for self and team.
Ability to work collaboratively within a project team.
Ability to work efficiently and effectively in a matrix environment.
1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Local project coordination and/or project management experience.
Thorough knowledge of Covance SOPs regarding site monitoring.
Job Number 2018-18847
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.