Merck Senior Specialist, Global Trial Optimization (Remote) in Sacramento, California
Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
The Senior Specialist, Global Trial Optimization(Sr. GTOS) develops program and study-level feasibility and operational parameters : Via study of evidence, uses, and may develop, specialized methodology to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Partners with Clinical Sciences & Study Management(CSSM) to align on deliverables. (25%)
Develops and recommends program and study-level recruitment and retention plan: Develops study-level patient outreach and recruitment vendor strategies, and, in partnership with CSSM Program Lead or Study Manager, develops implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)
Project management of recruitment tactics: The Sr. GTOS creates an execution plan for program and study-level recruitment and retention tactics. Includes country-specific details and ranges of contribution for each tactic. In partnership with program, study leads manage the implementation of these tactics especially related to recruitment and media vendors. (30%)
Personal and Professional Development: Attends training and conferences in patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to the Global Trial Optimization (GTO) function. (10%)
Contributes to training, and process improvement : Provide direction to more junior GTOS by demonstrating, on-the-job, the evidence-based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods and guides others re: application of informatics, simulation, and modeling. Provides training on systems and tools which promote Global Trial Optimization activities; inclusive of applications of performance metrics for Global Trial Optimization in order to utilize internal and external intelligence and refine methods and tactics on assigned projects. Maintain relationships with system and tool vendors and research new tools to enhance data capabilities. (10%)
- Under the supervision of manager, the Sr. GTOS identifies for the CSSM organization strategies and tactics that will be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our company's clinical trials. Participates in early identification of potential risks to those objectives. Participates in developing and implementing mitigation strategies when needed. Works with manager to align the operational execution plan with our Research & Development Division scorecard objectives.
- The Sr. GTOS conducts operational planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with management chain, the GTOS finalizes deliverables and identifies potential areas for process improvement.
- The Sr. GTOS will have strong diagnostic skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. Able to negotiate and influence stakeholders. Assess gaps between desired and feasible operational outcomes of clinical development programs, developing solutions to these, and then successfully promoting them are key skills.
The Sr. GTOS will be able to impart and express ideas clearly, orally and in writing, to develop operational parameters, recruitment and retention plans and other key GTO deliverables.
Represent GTO, with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review.
Able, with appropriate support, to influence team colleagues through data driven argument.
In general, will partner with the appropriate manager as they prepare for LDRC/EDRC review.
Influence / Liaison:
- The Sr. GTOS will be a representative to promote other Research & Development Division functional areas in the education and methodology of feasibility and patient recruitment science and a resource to operational field personnel implementing and managing recruitment and retention tactics at the site level. The GTO outputs for which a GTOS is responsible drive clinical supply planning, timing and feasibility assessment of clinical programs and studies, and LDRC contract dates.
- Position is likely, but not required to manage FSP sourced GTO staff.
- Will propose any feasibility and recruitment budget needs; to be reviewed with GO TA lead.
- Undergraduate degree (B.A./B.S.) or higher (medical/pharmaceutical/biological sciences preferred)
At least 5 years, including 3 years’ experience in the conduct of clinical trials and some knowledge in business process and continuous improvement.
Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to evaluate clinical data and synthesize medical evidence into a plan is a strength.
Demonstrated administrative and project management abilities in a relevant clinical development setting.
Stakeholder management and communication skills preferably practiced in an international clinical research environment
Oncology clinical trials is preferred.
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., 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Invent. Impact. Inspire.
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Requisition ID: R111449