Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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. Summarized Purpose: Performs and coordinates
different aspects
of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (
i.e.
FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted
in accordance with
the approved protocol, ICH-GCP guidelines, applicable
regulations
and SOPs to guarantee subjects rights,
well-being
and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Key responsibilities Monitors investigator sites with a risk-based monitoring
approach:
applies root cause analysis (RCA), critical thinking and problem-solving skills to
identify
site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters
in a timely manner
using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to
maintain
regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously
identified
issues are being resolved and that the data is being recorded
in a timely manner
. Conducts supervising tasks
in accordance with
the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates
in investigator meetings
as
vital.
Identifies
potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where
warranted
. Performs trial close out and retrieval of trial materials.
Ensures that
required
crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as
required
. Ensures study systems are updated per agreed study conventions (
e.g.
Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written,
oral
and/or electronic contacts.
Responds to company,
client
and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets
in a timely manner
.
Contributes to the project team by assisting in preparation of project publications/
tools, and
sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as
required
.
Keys to Success Education and Experience: Bachelor's degree in a
life sciences
related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous
experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1
years
as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable. Knowledge,
Skills
and Abilities: Proven clinical monitoring skills.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to
attain
and maintain a solid understanding of ICH GCPs, applicable
regulations
and procedural documents.
Well-developed critical thinking skills, including but not limited
to:
critical mindset, in-depth investigation for
appropriate root
cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes.
Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
Ability to
maintain
customer focus through the
utilization
of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
Good organizational and time management skills
Effective interpersonal skills.
Attention to detail.
Ability to
remain
flexible and adaptable in a wide range of scenarios.
Ability to work in a team or independently as
required
.
Good digital literacy: solid knowledge of Microsoft Office and the ability to learn
appropriate software
.
Good English language and grammar skills.
Good presentation skills.
Benefits We offer competitive
remuneration
, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier,
cleaner
and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity,
Innovation
and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological
innovation
and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate
on the basis of
race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,
disability
or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring
accommodations
in the job application process. For example, this may include individuals
requiring
assistance
because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or
assisting
a person with a disability, and require accessibility
assistance
or
an accommodation
to apply for one of our jobs, please
submit
a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility
assistance
or
an accommodation
in the job application process. Messages left for other purposes, such as not being able to get
into
the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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. Summarized Purpose: Performs and coordinates
different aspects
of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (
i.e.
FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted
in accordance with
the approved protocol, ICH-GCP guidelines, applicable
regulations
and SOPs to guarantee subjects rights,
well-being
and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Key responsibilities Monitors investigator sites with a risk-based monitoring
approach:
applies root cause analysis (RCA), critical thinking and problem-solving skills to
identify
site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters
in a timely manner
using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to
maintain
regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously
identified
issues are being resolved and that the data is being recorded
in a timely manner
. Conducts supervising tasks
in accordance with
the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates
in investigator meetings
as
vital.
Identifies
potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where
warranted
. Performs trial close out and retrieval of trial materials.
Ensures that
required
crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as
required
. Ensures study systems are updated per agreed study conventions (
e.g.
Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written,
oral
and/or electronic contacts.
Responds to company,
client
and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets
in a timely manner
.
Contributes to the project team by assisting in preparation of project publications/
tools, and
sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as
required
.
Keys to Success Education and Experience: Bachelor's degree in a
life sciences
related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous
experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1
years
as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable. Knowledge,
Skills
and Abilities: Proven clinical monitoring skills.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to
attain
and maintain a solid understanding of ICH GCPs, applicable
regulations
and procedural documents.
Well-developed critical thinking skills, including but not limited
to:
critical mindset, in-depth investigation for
appropriate root
cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes.
Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
Ability to
maintain
customer focus through the
utilization
of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
Good organizational and time management skills
Effective interpersonal skills.
Attention to detail.
Ability to
remain
flexible and adaptable in a wide range of scenarios.
Ability to work in a team or independently as
required
.
Good digital literacy: solid knowledge of Microsoft Office and the ability to learn
appropriate software
.
Good English language and grammar skills.
Good presentation skills.
Benefits We offer competitive
remuneration
, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier,
cleaner
and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity,
Innovation
and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological
innovation
and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate
on the basis of
race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,
disability
or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring
accommodations
in the job application process. For example, this may include individuals
requiring
assistance
because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or
assisting
a person with a disability, and require accessibility
assistance
or
an accommodation
to apply for one of our jobs, please
submit
a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility
assistance
or
an accommodation
in the job application process. Messages left for other purposes, such as not being able to get
into
the career website, following up on an application, or other non-disability related technical issues will not receive a response.