Senior Engineer, R&D Digital

Description

The company is a healthcare business working across Innovative Medicine and MedTech, with a focus on prevention, treatment and cures for complex diseases.

The Senior Engineer, R&D Digital sits within the CTM Solutions group and supports clinical trial study management and oversight systems, including CTMS, Site Payments and Access Provisioning.

The role acts as a link between the business side and key partners and stakeholders, working with business partners, IT and suppliers on customer enablement, metrics, user administration and support, system integrations, continuous improvement and change management.

The role is based in Horsham, PA, Spring House, PA or Raritan, NJ, and is posted under separate requisition numbers for the United States (R-100546), the United Kingdom (R-103906) and Belgium and Netherlands (R-103896). Applications to any of these are treated as one submission.

The company is an equal opportunity employer and reviews candidates on individual merit.

Responsibilities

• Find and put in place technology improvements that make CTM Solutions systems and processes work better, with clear, measurable value.
• Work out what study teams need and turn those needs into practical system and process solutions.
• Help with study build and upkeep, and make sure teams use the systems well across the whole study lifecycle.
• Handle end-user support requests from service tickets and shared mailboxes, following up promptly until they are resolved.
• Look for ways to improve workflows with automation, analytics and GenAI, staying within privacy, security, quality, compliance and human oversight rules.
• Coordinate release management, user acceptance testing and system integrations with IT, system owners and suppliers.
• Solve complex system and process problems alongside IT and vendors.
• Build and deliver training, guidance and reference materials so people can use systems and processes effectively.
• Run team meetings and take part in cross-functional projects.
• Support system and process audits, regulatory inspections and corrective and preventive actions.

Requirements

• A Bachelor's degree is required, ideally in health, science, information technology or a related field.
• At least 5 years of relevant experience running clinical trials at a pharmaceutical or medical device company, a contract research organization (CRO), or both, is required.
• Hands-on experience supporting IT systems and processes for clinical development, reporting tools, Office 365 and database administration is required.
• A solid grasp of the drug development process, including Good Clinical Practices (GCPs) and the FDA Code of Federal Regulations, is required.
• You must be able to build partnerships and influence people at every level of the organization.
• Strong communication, business partnering, problem solving and prioritization skills are required.
• A global business mindset is required.
• You must be able to travel up to 10% of the time, domestic or international.
• A Project Management or Process Improvement certification is preferred.
• Analytical reasoning, critical thinking, data savvy, digital fluency, digital strategy, engineering, product design, product development, product improvement, product portfolio management, report writing, research and development, safety orientation, SAP Product Lifecycle Management, statistics, technical credibility and technology skills are listed as preferred skills.
• Candidates with a disability who need an accommodation during the interview process should contact the company: external applicants through the careers contact page at and internal employees through AskGS.

Conditions

This is a hybrid role.

The anticipated base pay range is $109,000.00 to $174,800.00.

Benefits

• Eligible employees may join the company's consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Time off, subject to policy and date of hire: vacation of 120 hours per calendar year; sick time of 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington); holiday pay including floating holidays of 13 days per calendar year; work, personal and family time of up to 40 hours per calendar year; parental leave of 480 hours within one year of the birth, adoption or foster placement of a child; bereavement leave of 240 hours for an immediate family member or 40 hours for an extended family member per calendar year; caregiver leave of 80 hours in a 52-week rolling period; volunteer leave of 32 hours per calendar year; and military spouse time off of 80 hours per calendar year.
• Further general benefits information is available on the company careers site at