Associate Director, IRT & COA Services

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Interactive Response Technology (IRT) systems Program Manager oversees the successful execution of the IRT strategy for one or more drug/vaccine programs. Responsible for ensuring end-to-end support is provided to clinical project teams. Ensures all aspects of the IRT project plan (from protocol development through system closeout) are executed on time and with high standard quality. Ensuring vendors are planning and managing timelines and employing risk management techniques across all programs. Responsible to have operational visibility across all studies for a particular TA.

Responsibilities include coordinating standards and oversight of consistency across our therapeutic areas. Identify areas for process improvement and lead improvement activities. Applies IRT expertise to day-to-day activities when issues are escalated. Interacts with both technical and clinical staff to ensure their needs are addressed. Accountable for making decisions regarding IRT process, issue resolution, and deviations from standards. Provide consultation on PRO modality, benefits, risks, costs, and process.

Primary Activities:

• Develops / maintains relevant documentation, including applicable SOPs, job aids, and guidance documents. Defines process in collaboration with stakeholders and manages implementation plans.

• Effectively demonstrates key leadership standards.

• Serves as an IRT Subject Matter Expert (SME) to internal stakeholders.

• Functions in the IRT Program Manager role independently and works to resolve conflicts that are complex, cross departmental, or external to our company.

• Independently prioritizes work activities to align with team objectives and/or current activities.

• Responsible for performing cost / benefit analysis for IRT projects, as appropriate.

• Develops vendor-specific strategies for IRT projects. Provides input to cross-vendor project strategies.

• Analyzes data to identify areas for process improvements. Provides project leadership for process improvement activities.

• Makes decisions based on SOPs, working knowledge, available data and prior experiences. Makes decisions regarding IRT standards used by trial teams, determines if deviations from standards are permissible, and provides final go/no-go decision regarding custom system changes.

• Facilitates study-specific requirements discussions or issue resolution with internal and external stakeholders when warranted.

• Responsibilities may include confirming/denying utilization of IRT Systems, identifying current, and projecting future, IRT demand; reviewing vendor proposals and participating in vendor selection and qualification.

• Manages vendor performance and relationship(s). Responsibilities may include serving as a vendor manager, defining and implementing process with vendor representatives, monitoring and analyzing vendor and performance metrics, performing root cause analysis and identifying corrective actions, leading quarterly review meetings, and serving as a point of escalation for vendor issues.

• Ensures vendor system development processes align with our company's Quality and System Life Cycle expectations.

• Defines and adheres to system development and maintenance quality indicators. May define / revise / monitor an IRT dashboard, KPIs, or quality indicators.

• Monitors system change requests. Ensures adherence to IRT standards, works with the clinical project teams to identify necessary system changes and ensure completion of the changes through its life-cycle. Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards. Analyzes system changes for trending, and identification of process improvements.

• May provide support for successful integration of company and vendor systems. Responsibilities may include managing requirement specifications, issue resolution, development of enhancements, and process changes.

• May provide training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.

• Obtains internal and external stakeholder feedback on a regular basis; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.

• Mentors new or junior staff. May maintain training records and generate training reports as required for staff.

Education Minimum Requirements:

• BA/BS in Biology, Life Sciences, Computer Science, or related field.

Required Experience and Skills:

• 5 years’ experience in Clinical Supplies, Clinical Research, or Database design & development.

• Minimum 5 years’ experience in technology implementation (e.g. IRT, EDC, COA etc), project management.

• Effective written and verbal communication skills; ability to negotiate, resolve conflict and engage in decision-making with vendors, and influence across functional areas and organizations.

• Ability to lead cross-functional teams and organize / manage multiple tasks at one time.

• Demonstrated leadership and project management skills; exceptional organizational, communication, and problem-solving skills.

• Proficiency with Microsoft Applications (MS Project, PowerPoint, Word, Excel).

#EligibleforERP

MRLGCTO

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R222121