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Sr CRA (Level II) - Singapore

Pharmaceutical Product Development (PPD)

Singapore


PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a CRA, you will ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to help our clients deliver life-changing therapies to patients.

Responsibilities:

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures

Conducts site visits to assess protocol and regulatory compliance and manages required documentation

Responsible for ensuring that data will pass international quality assurance audits

Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel

May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members

Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role. CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a CRA, you will ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to help our clients deliver life-changing therapies to patients.

Responsibilities:

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures

Conducts site visits to assess protocol and regulatory compliance and manages required documentation

Responsible for ensuring that data will pass international quality assurance audits

Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel

May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members

Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role. CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Qualifications

Education and Experience:Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institutionSignificant clinical research monitoring experience (comparable to 3 years) that provides the required knowledge, skills and abilities and experience mentoring or training othersValid Driver's License where applicableIn some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be consideredKnowledge, Skills and Abilities:Effective clinical monitoring skillsExcellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating ProceduresAbility to mentor and train other monitors in a positive and effective mannerAbility to evaluate medical research data and proficient knowledge of medical terminologyEffective oral and written communication skills, with the ability to communicate effectively with medical personnelStrong customer focusExcellent interpersonal skillsStrong attention to detailEffective organizational and time management skillsProven flexibility and adaptabilityExcellent team player with team building skillsAbility to work independently as requiredAbility to utilize problem-solving techniques applicable to constantly changing environmentGood computer skills: good knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsEffective presentation skillsPPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable mannerAble to work upright and stationary for typical working hoursAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsThis role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains

Qualifications

Education and Experience:Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institutionSignificant clinical research monitoring experience (comparable to 3 years) that provides the required knowledge, skills and abilities and experience mentoring or training othersValid Driver's License where applicableIn some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be consideredKnowledge, Skills and Abilities:Effective clinical monitoring skillsExcellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating ProceduresAbility to mentor and train other monitors in a positive and effective mannerAbility to evaluate medical research data and proficient knowledge of medical terminologyEffective oral and written communication skills, with the ability to communicate effectively with medical personnelStrong customer focusExcellent interpersonal skillsStrong attention to detailEffective organizational and time management skillsProven flexibility and adaptabilityExcellent team player with team building skillsAbility to work independently as requiredAbility to utilize problem-solving techniques applicable to constantly changing environmentGood computer skills: good knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsEffective presentation skillsPPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable mannerAble to work upright and stationary for typical working hoursAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsThis role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains


2020-07-17 00:00:00


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