Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Activities
Develops program and study-level feasibility and operational parameters : Via analysis 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. Collaborates with 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 collaboration with CSSM PL or SM, 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 collaboration 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 bear on the GTO function. (10%)
Contributes to training, and process improvement: Provides leadership to less experienced 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 support Global Trial Optimization activities; inclusive of applications of performance metrics for Global Trial Optimization in order to leverage internal and external intelligence and support/refine methods and tactics on assigned projects. Maintain relationships with system and tool vendors and research new tools to enhance data capabilities. (10%)
Impact:
Under the supervision of their 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. Collaborates with manager to align the operational execution plan with our Research Division scorecard objectives.
Decision Making:
The Sr. GTOS conducts operational analyses and 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 their management chain, the GTOS finalizes deliverables and identifies potential areas for process improvement.
Problem Solving:
The Sr. GTOS must have strong analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. They must be able to negotiate and influence stakeholders. Assessing the gaps between desired and feasible operational outcomes of clinical development programs, developing solutions to these, and then successfully promoting them are key skills.
Expertise:
The Sr. GTOS should possess a Bachelor’s degree with at least 5 years or Master of Science degree with at least 3 years in medical/pharmaceutical/biological sciences with at least 5 years of career experience including minimum 3 years’ experience in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment.
Leadership:
The Sr. GTOS must be able to communicate and express ideas clearly, orally and in writing, to develop operational parameters, Recruitment and retention plans and other key GTO deliverables. They will represent GTO, with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review. They must be able, with appropriate support, to influence team colleagues through data driven argument. In general, will collaborate with the appropriate manager as they prepare for LDRC/EDRC review.
Influence / Liaison:
The Sr. GTOS will be a representative to support to other Research Division functional areas in the education and methodology of feasibility and patient recruitment science and a trusted 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.
People Management:
Position is likely, but not required to manage FSP sourced GTO staff.
MRLGCTO
#EligibleforERP
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., Rahway, 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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 Know Your Rights
EEOC GINA 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.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$107,600.00 – $169,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. – For Washington State Jobs, a summary of benefits is listed here .
Learn more about your rights, including under California, Colorado and other US State Acts
Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
25%
Flexible Work Arrangements:
Remote Work
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
No
Requisition ID:R239811
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