Job details
Job type full-time
Full job description
Job description
If this position will be based in the us or puerto rico (not applicable to positions based outside of us or puerto rico): subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for covid-19 or intend to be vaccinated for covid-19 by november 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirementHired candidates who are not vaccinated by november 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law
This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ich/gcp and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Specifically, this position will be responsible for the management and oversight of early stage development studies.
Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance for assigned protocols in a country in compliance with ich/gcp and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Reviews monitoring visits reports and escalates performance issues and training needs to cra manager and/or functional vendor and internal management as needed.
Performs quality control visits as required
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports cras as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Core competency expectations:
Knowledge in project management and site management.
Strong organizational skills with demonstrated success required.
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the ta head or crd
Requires strong understanding of local regulatory environment
Strong scientific and clinical research knowledge is required
Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions
Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
Proficiency in written and spoken english and local languageThe incumbent must be competent and effective in written and verbal communication.
Strategic thinking
Experience requirements (required):
5-6 years of experience in clinical research
Cra experience
Educational requirements (required):
Bachelor’s degree in science (or comparable)
**100% remote rol
** mrlgcto
We are a research-driven biopharmaceutical companyOur mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our worldWe 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 elseFor more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world`s most challenging diseasesToday, 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 comeWe encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organizationTogether we will continue inventing for life, impacting lives while inspiring your career growth.
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 packageTo discuss in more detail, please contact your hrbp or talent acquisition advisor.
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 capabilitiesPlease click here if you need an accommodation during the application or hiring process.
Pay transparency nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people togetherThe fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environmentWe encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectivelyWe are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search firm representatives please read carefully
Merck & co., inc., kenilworth, nj, usa, also known as merck sharp & dohme corp., kenilworth, nj, usa, does not accept unsolicited assistance from search firms for employment opportunitiesAll 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 companyNo 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 placeWhere agency agreements are in place, introductions are position specificPlease, no phone calls or emails.
Employee status:
Regular
Relocation:
No relocation
Visa sponsorship:
No
Travel requirements:
25%
Flexible work arrangements:
Flex time, remote work
Shift:
Valid driving license:
Hazardous material(s):
Number of openings:
1
Requisition id: r142445
