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Systems Implementation Leader (SIL)
Ref No.: 20-01571
Location: South San Francisco, California
Systems Implementation Leader (SIL)
Biopharmaceutical Industry
South San Francisco, CA 94080

Join a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.  The world's leading biotech company with multiple products on the market and a promising development pipeline. Join a team of highly dedicated, passionate individuals who take pride in a culture of openness, integrity and creativity. 

We are searching for a Systems Implementation Leader (SIL) who will serve as the primary point of contact and business partner for PDG Study Management Teams (SMTs) for all clinical systems and services that Systems and Process Excellence (SPE) offer. SILs are accountable for the setup, implementation and operations of the PDG suite of clinical operations systems, such as IxRS and eCOA. SILs have a high degree of expertise in customer relationship management, e2e study management processes and systems, and vendor management. By partnering with SMTs, SPE SILs identify new business opportunities within scope of SMT in support of continuous improvement and rigorous execution of clinical trials.

Primary Responsibilities & Accountabilities
  • Accountable to, and partners with the SMT and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials.
  • Manage the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout.
  • Understands business context and SMT goals to effectively partner with and continually assesses the needs of the SMT, to proactively translate business needs into system and process improvements.
  • Serves as first line of contact for triaging all SMT support and service requests for each clinical study.
  • Ensures prompt resolution of system issues, and provides timely and accurate responses to customers, as defined in service level agreements.
  • Proactively collaborates with other SPE sub-functions and beyond, to identify business needs and/or issues, and provides solutions to SMTs.
  • Monitors PDG clinical system key performance indicators (KPIs) and contributes to analysis to identify root causes for defects, to recommend process and/or system improvements.
  • Identifies process inefficiencies and compliance gaps, participates in process improvement initiatives and drives process implementation in support of SMTs.
  • Develops strong relationships and maintains effective communication within PDG, as well as other functional departments within the company in support of business goals and improvements.
  • Reports into the SPE-Operations Study Team Support (STS) Manager.
  • Bachelor’s degree with relevant certifications in project management (e.g., PMP) preferred.
  • Minimum 5 years’ experience in Biotech/Pharmaceutical industry, with relevant experience in systems and processes, and clinical operations or equivalent.

Experience, Skills, Knowledge
  • Knowledgeable with the processes and principles of program and customer relationship management, and business analysis.
  • Up-to-date knowledge of clinical operations processes and information systems. Understanding of internal/external system landscape
  • Experience managing third party vendors in delivering quality service as expected.
  • Ability to see and anticipate the interrelationship of systems and procedures within a project and understand their interdependencies – Systems thinking
  • Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience.
  • Previous experience in clinical trial planning and execution.
  • Ability to successfully lead teams or change initiatives through implementation with little or no oversight. Proven as a successful decisive leader in a strategic multifunctional environment, with proven ability to navigate organizational complexities.
  • Knowledgeable with Clinical Operations and Information Systems and processes such as IxRS, eCOA, CTMS, eTMF, RBM, EDC, and Clinical Supply Systems.
  • Demonstrated excellent judgment in recommending and executing conventional and novel solutions to protocol-specific requirements, and simplifying the trial’s system landscape as well as sustainability.
  • Demonstrated customer relationship management skills, and ability to create strong working relationships with respect to cultural diversity and working styles.
  • Business partner and stakeholder management: proven experience in building and cultivating trustful relationships both internally and externally
  • Excellent networking and influencing skills, effective working/leading in global and cross-functional (matrix) environment
  • Experienced in business needs analysis, identification of gaps/opportunities and development of recommendations for improvement
  • Ability to drive results to successful completion.
  • Analytical problem solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root causes and recommend solutions.
  • Comfortable working in a fast-paced, dynamic environment.
  • Highly proficient in functional tools such as Smartsheet (MS Project-equivalent).
  • Highly effective verbal & written communication skills.
  • Highly effective team player and interpersonal skills (globally, internal and externally).
  • Strong customer focus.