Director, Clinical Trial Management System Product Owner

Merck & Co., Inc. North Wales , PA 19454

Posted 2 months ago

Job Description:

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

Clinical Development heavily relies on compiling accurate operational data related to study, site, and patient in order to efficiently manage the end-to-end Clinical Trial process. Clinical Trial Management System (CTMS) solutions provide a centralized set of tracking and administrative capabilities for trial planning, executing and reporting functions.

Trial Management as a core business capability requires Research & Development (R&D) IT to focus on technology exploration and innovation, reduction of eco-system complexity, and an enriched user experience.

As R&D IT embarks into the transition from project / portfolio based execution to the product model, it is important to have an experienced Product Owner dedicated to this important capability.

Responsibilities:

The CTMS Product Manager will be accountable for the overall product and have primary responsibility to manage the product development process, build the vision and future strategy of the product tieing to value (OKRs), enforcing best practices of product development cycle like Test Driven development, Behavior driven development / DevOps principles, working with COTS (Commercial Of The Shelf) products.

The Product lead will also leverage their understanding of the technology stack of modern applications, ability to combine design / user needs with business expectations, ability to build/prioritize backlog with user stories and acceptance criteria.

The position is execution focused and will deliver product releases using Agile methodologies, the lead will also provide strategic roadmap and vision for the product as the technology landscape and new and innovative approaches of managing clinical trials evolves and emerges.

Use agile, value-centric, business outcomes-oriented, and total cost of ownership-based principles

Work closely with the R&D IT technology chapters, product line lead(s) and architect(s) to create an integrated roadmap and optimized execution for Clinical Development

Create and maintain current-state business/technology capability maps as well as future state roadmaps that will be relevant to the Trial Management product line

Stay current with clinical trial planning and execution trends and introduce these best practices to the company

Act/Become the Subject Matter Expert for clinical trial planning and execution

Define metrics for the measuring of technology maturity, health, and business value and play an active role in delivering these measures

Drive investment decisions with a mindset to optimize total cost of ownership in order to deliver maximum business value

Partner with Business System Owners, Product Line Leads and other Product Owners and work collaboratively towards a highly effective and efficient execution

Effectively work with both waterfall and agile project/product teams to evolve the technical landscape towards the desired end state

Apply risk-based decision making to complex problems and consult with relevant subject matter advisors as needed to inform the decision

Prepare and deliver executive level briefings and communicate complex topics effectively to a diverse executive audience

Education:

Bachelor's Degree in Computer Science, Systems Analysis, or a related study.

Qualifications:

12+ years prior working experience spanning IT roles including product management/ownership

  • Hands on experience with shaping and owning a digital product roadmap and vision

  • Strong background that comprises both solid business understanding as well as technical understanding of high-quality digital product delivery

  • Familiarity with customer journeys and customer experience, with reference to digital, design and services in pharmaceutical industry

  • Knowledge of Agile values, principles, and practices

  • Experience in managing geographically distributed squads

  • Active coach and mentor whose goals are to grow and maximize the squads potential

4+ years of leadership/management experience with the following:

  • Extensive leadership skills and experience in achieving shared objectives in a matrix organization leveraging cross-functional teams in an extremely dynamic environment

  • Demonstrated ability to partner with business stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs

  • Outstanding written and verbal communication skills - able to effectively communicate complex concepts in simple ways and align the organization on options and decisions

  • Strong collaborative skills and presentation experience with a variety of audiences and stakeholders including executive management, business leaders,IT peers, and colleagues worldwide

  • Strategic thinker who works in a broad and top-down manner with a fair amount of ambiguity at the center

  • Results-oriented with the proven ability and reputation for developing plans and implementing them successfully

  • Self-directed, self-motivated, focused leader who with little direction can fill in the gaps as to what is needed and drive expected results

  • Solid experience with envisioning the future and inspiring the organization / people towards a common goal

5+ years of software/application/product platform development or technical architecture experience with the following:

  • Experience working with SaaS, COTS and Cloud technologies

  • Familiarity with driving simplification of a digital product footprint with a focus on innovation, high-quality solutions and component re-use where applicable

  • Knowledge of and experience with CTMS solutions like Veeva Vault, Medidata Rave, Oracle Siebel or equivalent

  • Experience with System Development LifeCycle (SDLC)

  • Experience with GxP validations (Focus on GCP)

Preferred Skills:

Experience with the following activities:

Defining Objectives & Key Results (OKRs) and representing the voice of the customer for a digital product

Writing and prioritizing backlog user stories, focusing on business and engineering / technical requirements

Creating best-in-class product features with detailed analysis of impact and value

Participating in the planning of the Squad's sprint (and the Squad's next sprint) to reaffirm priorities, clarify requirements and delivery expectations with relevant stakeholders

Helping squads rapidly and iteratively deliver digital solutions that add value to the organization

Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Flex Time

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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Director, Clinical Trial Management System Product Owner

Merck & Co., Inc.