Program Manager, Clinical Database Services

Job Description

Responsibilities:

• Oversees and coordinates clinical database activities for clinical programs including the review of eCRFs, edit check specifications, and database development.
• Ensures adherence to clinical database standards, SOPs and Process Guidelines.
• Plans appropriately to ensure adherence to timelines for all clinical database services deliverables and escalate risks to management. Interface with members of study teams to integrate study team requirements into all deliverables.
• Interface with CDS manager/supervisor to assure consistency of technical and process strategies.
• Aligns others around a positive direction.
• Develops challenging but achievable objectives that clearly support stated organizational goals.
• Interacts and communicates clinical database processes and requirements to external vendors.
• Leads and participates in extra activities including, but not limited to, improvement task forces, automations, testing of new systems and helps coordinate CDS technical initiatives.
• Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group.
• Provides ongoing clinical database support to other departments.
• When necessary, may perform development activities such as database development or Peer Review.
• Provides oversight to Clinical Database Developers.
• Participates in the recruitment process, mentoring and training of new hires and ongoing technical development of Clinical Database Developers.
• Provides input into the performance appraisals of Clinical Database Developers to management.
• Ensures the adherence to standards in the development, documentation and maintenance of data dictionaries.
• If technically trained, performs as a Subject Matter Experts (SME) of clinical database and Electronic Data Capture activities including the creation of clinical databases and data transfer files.
• Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.
• Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations.

Minimum education required:

Bachelor's degree in computer science or related disciplines.

Required experience and skills:

• Minimum of 5 years pharmaceutical experience within clinical research
• Experience in technology acquisition and implementation
• 2 years project management experience (either one project for a year or multiple projects totaling one year)
• Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, standards and the development process in support of clinical research.
• Knowledge of Electronic Data Capture Systems or Data Management Systems
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Ability to establish and maintain good working relationships with different functional areas.
• Strong sense of urgency and customer focus.
• Possesses excellent communication skills and interacts effectively with Study Team.
• Strong organizational, time management, and multi-project coordination skills
• Broad knowledge of Clinical Development and Regulatory Affairs requirements
• Ability to multi-task, work independently, and good communication skills.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$130,960.00 - $206,200.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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, Remote Work

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Requisition ID:R252318