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Clinical Research Manager with Medical Background
PFIZER LUXEMBOURG SARL, organizačná zložka
Place of work
Tower 115, Pribinova 25, Bratislava region, Bratislava
Tower 115, Pribinova 25, Bratislava region, Bratislava
Contract type
full-time
full-time
Start date
by agreement
by agreement
Information about the position
Job description, responsibilities and duties
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Currently we are looking for:
Clinical Research Manager with Medical Background
This is what you can look forward to:
• You will be responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. Typically responsible for moderate to high risk / business critical studies and may have asset level responsibilities
• You will be accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g. study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g. site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction, particularly with INSPIRE sites
• You will be the local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc., and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level
•You will demonstrate leadership within the local clinical development environment with a goal to enhance our reputation in scientific leadership. The role is key in providing cross study, and cross site insights into the Clinical Development portfolio at the country/regional level
• Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation
• Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other RCSLs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
Please apply in English only!
Clinical Research Manager with Medical Background
This is what you can look forward to:
• You will be responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. Typically responsible for moderate to high risk / business critical studies and may have asset level responsibilities
• You will be accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g. study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g. site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction, particularly with INSPIRE sites
• You will be the local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc., and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level
•You will demonstrate leadership within the local clinical development environment with a goal to enhance our reputation in scientific leadership. The role is key in providing cross study, and cross site insights into the Clinical Development portfolio at the country/regional level
• Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation
• Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other RCSLs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
Please apply in English only!
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Educational Specialization
medical
Language skills
Slovak - Proficiency (C2) and English - Proficiency (C2)
Driving licence
B
Number of years of experience
2
Personality requirements and skills
What you can offer:
• A medical degree “MD” with active medical practice in minimum 1 year -
REQUIRED
• Must be fluent in Slovak and English. Multi language capabilities are an
advantage in this role
• PhD/MD with demonstrated clinical research experience and a track record of
delivery
• Extensive knowledge of clinical trial methodologies
• Demonstrated knowledge of clinical research and development processes and
ability to gain command of process details
• Demonstrated ability to influence local clinical trial environment
• Demonstrated knowledge in disease and technical areas pertaining to clinical
studies, including knowledge of company direction, investigational product(s),
and associated development plan(s)
• Demonstrated ability to lead, participate and support sponsor regulatory
interactions/inspections
• Demonstrated knowledge of the processes around protocol design and
feasibility assessment
• Demonstrated networking & relationship building skills
• Ability to evaluate, interpret and present complex issues and data to support
risk management and mitigation and to inform study/asset level decisions
• Ability to deal with ambiguity in the face of decision making
• Strong interpersonal skills required as well as excellent communication and
presentation skills
• Availability to travel within the region and/or globally as required
• A medical degree “MD” with active medical practice in minimum 1 year -
REQUIRED
• Must be fluent in Slovak and English. Multi language capabilities are an
advantage in this role
• PhD/MD with demonstrated clinical research experience and a track record of
delivery
• Extensive knowledge of clinical trial methodologies
• Demonstrated knowledge of clinical research and development processes and
ability to gain command of process details
• Demonstrated ability to influence local clinical trial environment
• Demonstrated knowledge in disease and technical areas pertaining to clinical
studies, including knowledge of company direction, investigational product(s),
and associated development plan(s)
• Demonstrated ability to lead, participate and support sponsor regulatory
interactions/inspections
• Demonstrated knowledge of the processes around protocol design and
feasibility assessment
• Demonstrated networking & relationship building skills
• Ability to evaluate, interpret and present complex issues and data to support
risk management and mitigation and to inform study/asset level decisions
• Ability to deal with ambiguity in the face of decision making
• Strong interpersonal skills required as well as excellent communication and
presentation skills
• Availability to travel within the region and/or globally as required
Advertiser
Brief description of the company
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Number of employees
50-99 employees
ID: 3124647
Posting date: 6.9.2017
2017-09-06
location: Tower 115, Pribinova 25, Bratislava region, Bratislava Position: Clinical Data Manager, Clinical Research Associate Company: PFIZER LUXEMBOURG SARL, organizačná zložka