Associate/manager Clinical Operations
hace 6 meses
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Our Clinical Operations team in Spain is rapidly growing, and we are looking for an **Associate/Manager Clinical Operations** in Madrid or Barcelona to oversee daily line management responsibilities of the assigned team. This role serves as positive leadership and professional role model for respective staff, which may include CAS, CS, CRAs, Assistant CRAs and CTCs. Provides direct coaching and development support to operational teams. Ultimately responsible for effective resourcing, alignment, training and on-going professional and technical development for staff. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Primary focus on line and performance management of team members assigned to any monitoring modality and/or environment (i.e.FSO, FSP, Government, etc.). Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
**A day in the Life**:
- Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
- Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables.
- Participates in process improvement/development initiatives.
- Ensures understanding and facilitation of the risk-based monitoring approach.
- Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
- Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
- Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
- Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
**Keys to Success**:
- Bachelor's degree in life-science or equivalent and relevant formal academic / vocational qualification
- Relevant clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership/mentoring/supervisory responsibility within Pharmaceutical or Clinical Research Organisation
- Fluency in both Spanish and English languages is essential
- Excellent clinical trials monitoring skills; Remote and on-site
- Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Demonstrated ability to evaluate medical research data
- Strong organizational and negotiation skills
- Advanced written and oral communication skills. Fluency in both Spanish and English languages is essential
- Demonstrated use of computer to include data entry, archival and retrieval
- Ability to travel as needed
- Excellent team player with team building skills
- Excellent interpersonal and conflict resolution skills
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas an
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