Director, Clinical Data Services Product Management

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Director, Clinical Data Services Product Management will be an employee of Emmes Clinical Operations/Clinical Data Services Department and reporting to Global Head of Clinical Data Services / SVP Global Clinical Operations. The position will be responsible for leadership and oversight of deployment of Advantage eClinical Cloud (AEC) and implementation by all Emmes' CRO global client delivery elements and be the primary interface with the Advantage eClinical Software Development team (Soft Dev).

Responsibilities

• Serve as the Director, Clinical Data Services Product Management and owner of the Advantage eClinical Cloud software deployments including:
  • Act as the primary POC/interface with Soft Dev for Emmes CRO portfolio of studies
  • Responsible for the prioritization of features/enhancements requested from Emmes CRO to Soft Dev for inclusion in AEC. Negotiate timelines, specifications, work arounds with the Soft Dev team and scheduling/coordinating Emmes CRO study teams
  • Serve on the Emmes CRO governance committee (may Chair) including oversight and approval of data structures, standard forms library, edit checks and planned changes/modifications
  • Accountable for the Emmes CRO adoption of AEC new features as releases are deployed
  • Oversight and accountability of AEC study delivery by all Emmes CRO staff globally including strategic rollouts, project management activities, and quality
  • Responsible for creation and maintenance of AEC data system related SOPs and work practices, including identifying efficiencies and process improvements; coordinate activities with Global Clinical Operations Process Optimization to ensure alignment/updates to corporate RACI and SOPs
  • Escalate issues to Exec Operations Comm
• Execute the remaining steps on the IT Cadre Future State Roadmap as Emmes CRO is ready to implement them
• Provide AEC status reports to Clinical Data Services and corporate Exec Committee, recommendations for AEC usage/changes, and accountable for AEC-related timelines, quality delivery, budget, metrics, etc.
• Liaise with Director, Clinical Data Management, Director, Clinical Data Systems, Director, Computing Services, Advantage Soft Dev and Sales team, Exec Team and other stakeholders on feedback, communications, strategy for AEC implementation and management
• Responsible for approving training curriculum, monitoring level of effort for AEC activities, and acting on quality issues related to Emmes CRO staff training
• Monitoring costs and burn in ongoing deployments and engaging with corporate pricing and financial operations to assess and update pricing models and study or client factors affecting cost
• Evaluating, engaging, and overseeing potential 3rd party vendors for AEC deployment support
• Representing Emmes CRO as a power user of AEC in a business development context including online user groups or other external forums
• Participate in bid defenses involving AEC bids

Experience

• Bachelor's degree, preferably in public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
• Incumbent will typically possess at least 15 years of progressive Clinical Data Systems and strong understanding of clinical research and/or Clinical Data Systems processes, including at least 7 years progressive CDS lead or supervisory experience
• Knowledge of GCP and applicable regulatory guidelines
• Experience in pharmaceutical industry and/or contract research organization strongly preferred
• Expertise in clinical electronic data capture (EDC) system deployments. Note: Leader will be trained to serve as a technical expert on AEC (no prior experience in Advantage required)
• Knowledge of software development lifecycle activities; experience with Agile/Scrum strongly preferred
• Excellent organizational and time management skills, particularly during tight timelines
• Highly motivated and results-driven with unyielding predisposition to detail, accuracy, and clarity
• Track record of successful delivery of complex, multi-stakeholder software programs, preferably EDC projects
• Strong leadership, communication skills and collaboration skills with software Product Managers, delivery teams, agile teams, and corporate stakeholders
• Excellent verbal, written, presentation, and interpersonal communication skills with ability to champion change, inspire others to high performance, build relationships, and collaborate effectively
• Demonstrated ability to think critically, analyze situations, innovate, practice self-development, and set strategic priorities
• Portfolio and project management experience including management of timelines, budgets, and resources for biopharma and public sector clients
• Knowledge of Microsoft Office suite is essential

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

· Unlimited Approved Leave

· Tuition Reimbursement

· 401k & Profit Sharing Plan

· Work From Home Anywhere in the US

· Maternal/Paternal Leave

· Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.