Scientist, Clinical Trial Optimization
Apply NowCompany: Merck & Co, Inc
Location: North Wales, PA 19454
Description:
Job Description
Contributes to program and study-level feasibility and operational parameters: Via gathering and reviewing of evidence, uses, and contributes to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Collaborates with senior Global Technical Operations staff, CSSM to align on deliverables. (25%)
Contributes to program and study-level recruitment and retention plan: initiates study-level assessment of patient recruitment needs and considers outreach and recruitment vendor strategies, in collaboration with senior
Global Technical Operations staff. May contribute to implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)
Project management of Enrollment Support Tactics: the
Global Technical Operations authors or manages vendor authoring of study-level enrollment support material. Includes country specific translation and delivery timelines in alignment with overall study timelines. (30%)
Personal and Professional Development: Attends training and conferences in Patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to bear on the
Global Technical Operations function. (10%)
May contribute to training, and process improvement: provide leadership to less experienced Global Technical Operations by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on Global Technical Operations methods and guides others re: application of informatics, simulation, and modeling. (10%)
Impact
Under the supervision of his/her manager, the Global Technical Operations authors and delivers Global Technical Operations contributions to assigned clinical trial teams. These contributions be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our company's clinical trials. The Global Technical Operations may participate in early identification of potential risks to those objectives. The Global Technical Operations may participate in developing and implementing mitigation strategies when needed. Collaborates with manager to align the operational execution plan with our Research and Development Division scorecard objectives.
Decision Making
Under the supervision of their management, the Global Technical Operations conducts operational analyses and planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with his/her management chain, the Global Technical Operations finalizes deliverables and identifies potential areas for process improvement.
Problem Solving
The Global Technical Operations must have good analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. He/she must exhibit a developing skill set in negotiating and influencing stakeholders.
Expertise
The Global Technical Operations should possess a Bachelor of Science degree in medical/pharmaceutical/biological sciences with at least 3 years of career experience including 2 years in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment.
Leadership
The Global Technical Operations must be able to communicate and express ideas clearly, orally and in writing, to contribute to operational parameters, recruitment and retention plans and other key Global Technical Operations deliverables. He/she may represent Global Technical Operations , with support from management and GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review.
Influence / Liaison
Under the supervision of their manager, the Global Technical Operations will be a representative to support to other CTT functional areas in the education and methodology of feasibility and patient recruitment science and a trusted resource to operational field personnel implementing and managing recruitment and retention tactics at the site level. The Global Technical Operations outputs for which a Global Technical Operations is responsible drive Clinical supply planning, timing and feasibility assessment of clinical programs and studies, and LDRC contract dates.
Qualifications, Skills & Experience
Functional Area
Clinical Research
Job Family
Clinical Research Generic
Management or Individual Contributor
Individual Contributor
Geographical Scope
#eligibleforerp
ResearchandDevelopmentGCTO
VETJOBS
EBRG
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/23/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Contributes to program and study-level feasibility and operational parameters: Via gathering and reviewing of evidence, uses, and contributes to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Collaborates with senior Global Technical Operations staff, CSSM to align on deliverables. (25%)
Contributes to program and study-level recruitment and retention plan: initiates study-level assessment of patient recruitment needs and considers outreach and recruitment vendor strategies, in collaboration with senior
Global Technical Operations staff. May contribute to implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)
Project management of Enrollment Support Tactics: the
Global Technical Operations authors or manages vendor authoring of study-level enrollment support material. Includes country specific translation and delivery timelines in alignment with overall study timelines. (30%)
Personal and Professional Development: Attends training and conferences in Patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to bear on the
Global Technical Operations function. (10%)
May contribute to training, and process improvement: provide leadership to less experienced Global Technical Operations by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on Global Technical Operations methods and guides others re: application of informatics, simulation, and modeling. (10%)
Impact
Under the supervision of his/her manager, the Global Technical Operations authors and delivers Global Technical Operations contributions to assigned clinical trial teams. These contributions be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our company's clinical trials. The Global Technical Operations may participate in early identification of potential risks to those objectives. The Global Technical Operations may participate in developing and implementing mitigation strategies when needed. Collaborates with manager to align the operational execution plan with our Research and Development Division scorecard objectives.
Decision Making
Under the supervision of their management, the Global Technical Operations conducts operational analyses and planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with his/her management chain, the Global Technical Operations finalizes deliverables and identifies potential areas for process improvement.
Problem Solving
The Global Technical Operations must have good analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. He/she must exhibit a developing skill set in negotiating and influencing stakeholders.
Expertise
The Global Technical Operations should possess a Bachelor of Science degree in medical/pharmaceutical/biological sciences with at least 3 years of career experience including 2 years in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment.
Leadership
The Global Technical Operations must be able to communicate and express ideas clearly, orally and in writing, to contribute to operational parameters, recruitment and retention plans and other key Global Technical Operations deliverables. He/she may represent Global Technical Operations , with support from management and GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review.
Influence / Liaison
Under the supervision of their manager, the Global Technical Operations will be a representative to support to other CTT functional areas in the education and methodology of feasibility and patient recruitment science and a trusted resource to operational field personnel implementing and managing recruitment and retention tactics at the site level. The Global Technical Operations outputs for which a Global Technical Operations is responsible drive Clinical supply planning, timing and feasibility assessment of clinical programs and studies, and LDRC contract dates.
Qualifications, Skills & Experience
- Bachelor's Degree (Life-science related)
- 2 years of clinical trial related experience (Entry level to function with previous experience in the conduct of clinical trials required)
Functional Area
Clinical Research
Job Family
Clinical Research Generic
Management or Individual Contributor
Individual Contributor
Geographical Scope
#eligibleforerp
ResearchandDevelopmentGCTO
VETJOBS
EBRG
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/23/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.