Associate Director, Clinical Outcome Assessments

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.

Clinical Outcome Assessments (COA Program Manager oversees the successful execution of the COA 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 COA 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 COA 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 COA 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 a COA Subject Matter Expert (SME) to internal stakeholders.

• Functions in the COA 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 COA projects, as appropriate.

• Develops vendor-specific strategies for COA 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 and COA 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 COA Systems, identifying current, and projecting future, COA 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.

Education:

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

Experience:

• 6 years’ experience in Clinical Data Management or Clinical Outcome Assessments (COA) systems or related industry experience

• At least 3 years of supervisory or management experience

• Strong knowledge of the Drug Discovery or Drug Development Process, ICH and GCP guidelines

• Working knowledge of database structures, COA/Data Management Tools & Technologies

Knowledge and Skills:

• Strong organizational, time management, problem solving and project coordination skills.

• Exceptional communication skills(oral and written), with the ability to communicate with both the technical and business areas.

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

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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” that great medicines can make a significant impact to our world. 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.

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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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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.

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Relocation:

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Requisition ID:R222366