Job Description
The CDT Program Manager is a member of the Clinical Database Testing Team. As a member of the CDT Team the CDT Program Manager will be involved with the creation and execution of Quality Control and User Acceptance Testing procedures for electronic data capture systems, and the various components that make up the electronic data capture system. They should understand the System Development Lifecycle and understand the importance of User Acceptance Testing. As a more senior member of the team the CDT Program Manager will be a subject matter expert on the electronic data capture testing procedures and will ensure the recording of test data and test results in accordance with standard operating procedures. Participation in cross functional process improvement projects is expected.
Responsibilities:
Be able to support any role or task into the team when needed.
May support data management process owner (PO); Person is a subject matter expert on CDT process, may be responsible for the updating and the maintenance of CDT SOP’s and supporting documentation.
May be responsible for compliance review and approval of CDT UAT documentation.
Continually monitors for opportunities for process improvement; to improve efficiency and effectiveness of the CDT group, additionally the person should implement changes as appropriate.
May be assigned to lead or participate in cross functional technical and/or process improvement projects.
As SME the person may participate in the development of job specific training material, with MPI, and deliver training material as needed to the staff.
May be assigned to a lead role for larger, and more complex or higher risk clinical trial programs, to ensure consistency across teams.
Education:
At least B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.
Knowledge and Skills:
4+ years of System Development Lifecycle Management.
System validation knowledge.
Should have a strong understanding of SDLC process.
Database design and development knowledge.
An overall working knowledge of the clinical development process.
Knowledge of database structures and available tools to manage, extract, and report data is preferred.
Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
Exceptional organizational and problem-solving skills.
Ability to work cross functionally and as part of a team.
Able to work under pressure and change environment with flexibility.
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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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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”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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
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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:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
12/7/2024
*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.
