This job listing has expired and the position may no longer be open for hire.

Senior Clinical Scientist at WIRB-Copernicus Group

Posted in Other 30+ days ago.

Location: New York, New York





Job Description:

The Senior Clinical Scientist provides scientific leadership and indication expertise for all
assigned projects and is seen as a resource when interacting and communicating with investigative sites,
study sponsors, and internal stakeholders ensuring quality and timely delivery of all clinical service offerings.
The Senior Clinical Scientist is the MA-PP therapeutic area expert in attendance at all external meetings.
The Senior Clinical Scientist shares the responsibility of leading assigned projects with Project Management
and is relied upon cross-departmental y to ensure the success of the project. Through their scientific
leadership and clinical expertise applied to their projects, the relationships they develop with their clients
help to grow the business.

EDUCATION REQUIREMENTS:
* Graduate degree in a life science discipline or other field relevant to the MedAvante-ProPhase
business focus is required.

QUALIFICATIONS/EXPERIENCE:
* Seven years of experience in the clinical research industry required; experience working for a
biopharmaceutical sponsor or a clinical research organization preferred
* Minimum 5 years of experience as a Clinical Scientist, clinical trial science lead or similar role, with
external-facing responsibilities managing the clinical aspects of a clinical trials, with demonstrated
ability to leverage scientific concepts to influence external audiences and/or clients required
* Minimum 4 years of experience with the administration of rating scales with practical knowledge
of study endpoints as part of sponsored clinical research required
* Strong communication and negotiation skil s across audiences, demonstrated by ability to assess
complex situations, devise impact-generating solutions based on incomplete data and the ability
to present complex information in a simplified way is required
* Demonstrated leadership skills and ability to integrate in a team, motivate others and communicate
clearly and effectively
* Strong problem solving/decision making skills demonstrated by ability for independent critical
thinking, solution generation and engagement in active scientific exchange
* Solid understanding of intermediate research methods and statistics; having research publications
strongly preferred
* Expert knowledge of Good Clinical Practice (GCP)
* Fluent in English required; bi-lingual or multi-lingual skills are preferred
* Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce
detailed reports and presentations using these tools

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, the individual must be able
to perform each essential duty and responsibility satisfactorily. The requirements listed below are
representative of the knowledge, skills, and/or ability required.
* External facing clinical representative responsible for the independent clinical management of large,
international clinical trials
* Own scientific responsibility and co-leads each assigned project, along with accountability for
ensuring that the scientific integrity is maintained and all necessary analyses and remediations are
conducted and effectively communicated.
* Provides expert support and mentoring for all advanced solutions in line with demonstrated
advanced knowledge and experience with al service offerings, leveraging strong communication
and negotiation skills and strategies. This includes, but is not limited to, advanced analytics;
independent review/rating analysis and remediations, etc.
* Partner with all departments, including business development, to build relationships internally and
external y to promote strategic development and grow the business.
* Lead clinical discussions and follow through in internal and external project meetings (e.g., weekly
external client call, Investigator Meetings).
* Review, monitor, and proactively address issues regarding study level metrics; present study
dashboards to sponsors by reviewing data, any outliers or areas of concern, as well as any actions
taken to address these concerns
* Ensure clinical quality standards are met by monitoring internal clinician and team level
performance across studies and scales and resolve clinical quality or training related issues.
* Responsible for the calibration of clinical team, conducting rater training events, and remediations
as specified in the study-specific training plans
* Proactively identify and address project related risks through active communication across
departments and adherence to policy/procedure. Resolve and communicate quality events
promptly and effectively
* Participate in the mentoring and training of Clinical Scientists.
* Develop and nourish peer-to-peer relationships with clients, external consultants, key opinion
leaders, and clinicians, both regionally and in research areas of interest.
* Actively participate in research and publications efforts and report research results externally
through peer-reviewed journals, conferences, or other appropriate venues is required.
* Identify the need for and contribute to the development of departmental and cross-disciplinary
work instructions, process guidelines and standard operating procedures to ensure all processes
and procedures meet SOP/GCP requirements.
* Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position
described here.
* Attendance and punctuality are essential functions of the position.


SUPERVISORY RESPONSIBILITIES: The position may require the individual to be responsible for the
management, direction, coordination, performance, and evaluation of an assigned team and staff.
Responsibilities may include training employees; planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing complaints and resolving problems.

TRAVEL REQUIREMENTS:
This role may require up 20% travel which may be domestic or international
The Senior Clinical Scientist provides scientific leadership and indication expertise for all
assigned projects and is seen as a resource when interacting and communicating with investigative sites,
study sponsors, and internal stakeholders ensuring quality and timely delivery of all clinical service offerings.
The Senior Clinical Scientist is the MA-PP therapeutic area expert in attendance at all external meetings.
The Senior Clinical Scientist shares the responsibility of leading assigned projects with Project Management and is relied upon cross-departmental y to ensure the success of the project. Through their scientific
leadership and clinical expertise applied to their projects, the relationships they develop with their clients
help to grow the business.

EDUCATION REQUIREMENTS:
* Graduate degree in a life science discipline or other field relevant to the MedAvante-ProPhase
business focus is required.

QUALIFICATIONS/EXPERIENCE:
* Seven years of experience in the clinical research industry required; experience working for a
biopharmaceutical sponsor or a clinical research organization preferred
* Minimum 5 years of experience as a Clinical Scientist, clinical trial science lead or similar role, with
external-facing responsibilities managing the clinical aspects of a clinical trials, with demonstrated
ability to leverage scientific concepts to influence external audiences and/or clients required
* Minimum 4 years of experience with the administration of rating scales with practical knowledge
of study endpoints as part of sponsored clinical research required
* Strong communication and negotiation skil s across audiences, demonstrated by ability to assess
complex situations, devise impact-generating solutions based on incomplete data and the ability
to present complex information in a simplified way is required
* Demonstrated leadership skills and ability to integrate in a team, motivate others and communicate
clearly and effectively
* Strong problem solving/decision making skills demonstrated by ability for independent critical
thinking, solution generation and engagement in active scientific exchange
* Solid understanding of intermediate research methods and statistics; having research publications
strongly preferred
* Expert knowledge of Good Clinical Practice (GCP)
* Fluent in English required; bi-lingual or multi-lingual skills are preferred
* Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce
detailed reports and presentations using these tools

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, the individual must be able
to perform each essential duty and responsibility satisfactorily. The requirements listed below are
representative of the knowledge, skills, and/or ability required.
* External facing clinical representative responsible for the independent clinical management of large,
international clinical trials
* Own scientific responsibility and co-leads each assigned project, along with accountability for
ensuring that the scientific integrity is maintained and all necessary analyses and remediations are
conducted and effectively communicated.
* Provides expert support and mentoring for all advanced solutions in line with demonstrated
advanced knowledge and experience with al service offerings, leveraging strong communication
and negotiation skills and strategies. This includes, but is not limited to, advanced analytics;
independent review/rating analysis and remediations, etc.
* Partner with all departments, including business development, to build relationships internally and
external y to promote strategic development and grow the business.
* Lead clinical discussions and fol ow through in internal and external project meetings (e.g., weekly
external client call, Investigator Meetings).
* Review, monitor, and proactively address issues regarding study level metrics; present study
dashboards to sponsors by reviewing data, any outliers or areas of concern, as well as any actions
taken to address these concerns
* Ensure clinical quality standards are met by monitoring internal clinician and team level
performance across studies and scales and resolve clinical quality or training related issues.
* Responsible for the calibration of clinical team, conducting rater training events, and remediations
as specified in the study-specific training plans
* Proactively identify and address project related risks through active communication across
departments and adherence to policy/procedure. Resolve and communicate quality events
promptly and effectively
* Participate in the mentoring and training of Clinical Scientists.
* Develop and nourish peer-to-peer relationships with clients, external consultants, key opinion
leaders, and clinicians, both regionally and in research areas of interest.
* Actively participate in research and publications efforts and report research results externally
through peer-reviewed journals, conferences, or other appropriate venues is required.
* Identify the need for and contribute to the development of departmental and cross-disciplinary
work instructions, process guidelines and standard operating procedures to ensure all processes
and procedures meet SOP/GCP requirements.
* Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position
described here.
* Attendance and punctuality are essential functions of the position.

SUPERVISORY RESPONSIBILITIES: The position may require the individual to be responsible for the
management, direction, coordination, performance, and evaluation of an assigned team and staff.
Responsibilities may include training employees; planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing complaints and resolving problems.

TRAVEL REQUIREMENTS:
This role may require up 20% travel which may be domestic or international,
including overnight and weekend stays, consistent with project needs and office location.



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