Clinical Research Manager

Ubicación: 

Sant Cugat del Valles, ES

Tipo de Contrato:  Indefinido tiempo completo
Área:  Ensayos Clínicos
Número de solicitud de puesto:  221249

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.

With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California). Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.

Help us lead on of the world's largest pharmaceutical companies!
 
As a Clinical Research Manager you will oversee the clinical feasibility assessment and strategic planning of clinical trial programs or studies. You will execute global programs in assigned therapeutic area(s) from decision to start a clinical development up to the market authorization.  You will manage budgets, timelines and quality of deliverables for assigned programs and studies in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols.     


 What your responsibilities will be
 
You will have the opportunity to:


•    Assess best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders.
•    Manage clinical timelines, budgets, and resources against the approved Clinical Development Plan.
•    Identify risks, mitigations, opportunities and contingency plans for assigned programs and studies.
•    Escalate significant issues on programs and studies to senior management in a timely manner.
•    Oversee integrity of clinical data to ensure data meets GCP standards.
•    Participate in cross functional project teams and presents program information to internal and external audiences.
•    Provide clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g.IND, CTA, BLA, MAA).
•    Manage direct reports through performance evaluations and addressing professional development. Ensures compliance of each Clinical Development trial team with the trial-specific training requirements.
•    Contribute to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager.
•    Offer guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
•    Partner with Biometry to develop the case report form, data management plan and statistical management plan. Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis. Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
•    Maintain awareness of SAEs that are reported and oversees SAE/SUSAR reporting to EIC/IRB and Principal Investigators, when applicable.
•    Contribute to preparation of site inspections, attends site inspections, and supports responses to site inspections.
•    Supervise quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.
 
Who you are


•    You have a Life Sciences Degree. Master Degree in Clinical Development would be a plus
•    You have a minimum of 10 years experience in clinical research with at least 6 years in a similar role in international CRO or pharmaceutical company overseeing/managing international studies
•    You have a Native level of Spanish and Advanced in English.
•    You have good knowledge of Microsoft Office, eTMF, and EDC platforms.
•    You have in-depth knowledge of ICH GCPs, FDA and EMA regulatory requirements.
•    You have good leadership skills in supervising direct reports as well as motivational and critical thinking skills.
•    You have good oral and written communication skills for dealing with variety of subject matter experts across multiple departments.
•    You have flexibility and ability to handle multiple tasks for accomplish priorities while delivering high quality work in a dynamic environment.
•    You have a basic knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
•    You have ability and willingness to travel.
 
What we offer 


•    Permanent position in a dynamic and cross-functional global team.


This is a brilliant opportunity for you. Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply. We look forward to receiving your application!
Grifols is an equal opportunity employer.

 

 

Location: SPAIN; España; Sant Cugat del Valles.

 

Learn more about Grifols