Abbott Clinical Project Leader in Madrid, Spain
This position will be based in Barcelona (home based) but initially requires a training period of 1-2 months in Madrid.
1.- Manage the business
1.1 Project management
Review and/or translation of clinical investigation plan or summary, patient documentation (Information, Consent) and case report forms, presentation of study to potential investigators, submission to local authorities, ethical committees and hospital/clinic administrative services, contractual issues incl. investigator’s, follow-up of recruitment progress, payments, and data collection and proceeding progress in co-ordination with Data Management unit.
Prepare all documentations requires for submission to local authorities, ethical committees to evaluate a project. Manage the contracts with the sites. Notify informed consent documents for local needs, ensure ICD legibility.
Ensure that reportable SAE's are reported according to company and local regulatory requirements. Coordination of safety evaluation by checking/performing the appropriate documentation for declaration process of adverse events to authorities and/or competent bodies according to applicablelaws, rules and procedures, helping for preparation of review boards or steering committees by supporting classification of adverse events.
Participation to international clinical studies, monitoring the quality and results in accordance with the protocol under co-ordination of Clinical Managers: Review and/or translation of clinical investigational plan and case report forms, choose of local investigators, submissions to local authorities, etc.
Preparation of audits and attendance on site when possible/necessary
Application of Standard Operating Procedures, Good Clinical Practices as defined in Clinical Investigation of Medical Devices legislation
Help in identifying site/protocol trends to execute adequate action plans.
Budget, define cost and help to identify resources needed for study implementation.
1.2 Site Management
Logistic and technical expert support to clinical department, attendance to patients’ follow-ups, collection of technical and clinical data on CRFs on site, ensure to achieve the enrollment plans.
Supports physicians during the enrolment and follow up phase of clinical studies. Detect and escalate any issues related to the study site, in a systematic and timely manner. Design, propose and implement actions plans to address identified issues.
Perform stand duty
Train sites in CRF's completion as well as how to answer to queries correctly and the relevance and their responsibility to provide a timely response to queries.
Frequent travel to visit investigational centers (Local and foreign countries) and to attend meeting with project team and/or operational/functional organization
Budget ensures payments are done according to contracts.
Administrative task related to the successful progress of the study under supervision of Clinical Managers with other involves CRAs or CFEs.
1.3 Problem solving & innovation this job requires that the incumbent identifies and analyses problems, makes timely proposals for solutions and decisions. Discuss them with management.
1.4 Team work & Attitude, implementation of all new systems necessary for the studies. Support group initiatives in cooperation with other relevant team members.
1.5 Customer Orientation & Communication, Main point of contact for the study. Efficiently communicate expectation to the site and get agreements in critical points. Communicate effectively with all members of the team locally, globally and with the investigator sites.
1.6 Performance Development, develop personal and technical skills in line with the Curriculum map and with the aid of the supervisor. Examples are communication, interpersonal, presentations skills, and medical knowledge of therapeutic areas as necessary. Attend company and external meetings and symposiums as appropriate and present the affiliate.
This position is in contact with customers.
To ensure that all EMEA current Business Ethics, Regulatory and Quality procedures are followed.
Represent the Company in a professional manner and with the highest integrity.
To report and keep his/her immediate Manager informs about his/her business progress and assisting him/her to be able to build the yearly operating plan.
Maintain business operations in accordance with corporate policies with respect to pricing, quotes, credit terms, and expense reporting.
Proactively plan their weekly travel schedule and communicate this through the appropriate channels in your country/division.
The position is in contact with Customers.
Responsibilities for all functions:
In case the employee is being made aware of an event or complaint in relation to a product distributed by ABBOTT, he/she shall report this in compliance with the SOP 50558 on Field Event Reporting.
When tasks and responsibilities are assigned outside the scope of normal duties, the employee must understand the level of decision making for which he/she is responsible and if in doubt clarify this with his/her supervisor.
Section 3: EDUCATION & COMPETENCIES
School or University qualifications
- University degree preferably in life health sciences.
Knowledge and skills (e.g. languages, PC, …)
Cardiological science, clinic and/or physiology, pacing/defibrillation technologies
Experienced FCE or Studies Manager (0-4 years)
English fluent (and Third language) if possible
Clinical investigation in pharmaceutical industry, medical device or CRO
Natural abilities (team player, stress resistant, discretion, good communicator, etc.)
- Team player, good interpersonal skills, confidentiality, teamwork attitude, problem solving, customer orientation.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org