Job type full-time
Benefits pulled from the full job description
Full job description
Our clinical research and pharmacovigilance team push the boundaries of global healthcare through research and innovationThrough clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with international conference on harmonization good clinical practice (ich/gcp) and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externallyFor certain studies, the clinical research manager (crm) could be accountable for several countries in a cluster.
Responsibilities include, but are not limited to:
Main point of contact (poc) for assigned protocols and link between country operations and clinical trial team (ctt).
Accountable 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 closeout.
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 partners with and supports clinical research associates (cras) as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Accountable for creating and executing a local risk management plan for assigned studies
Ensures compliance with clinical trial management system (ctms), electronic trial master file (etmf) and other key systems in assigned studies
Escalates as needed different challenges and issues to ta head/clinical research director/clinical quality manager and or ctt (as appropriate)
Accountable for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country poc for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his /her country (if delegated can sign contracts and manage budgets)
Collaborates internally with hq functions and locally with pv , regulatory and global medical affairs ( gma ) to align on key decisions in his /her studiesHuman health to be consulted as needed.
As a customer-facing role, this position will build business relationships and represent our company with investigators
Shares protocol-specific information and best practices across countriesclusters
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 cr
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.
Behavioral competency expectations:
Strong leadership skills that enable and drive alignment with the goals, purpose and the mission of our company’s research labs, global clinical development (gcd) and global clinical trial operations ( gcto)
Ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical.
Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruptionExamples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations
Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Bachelor’s degree in science (or comparable)
Preferred: advanced degree, (e.g., master’s degree, md, phd)
5 + years of experience in clinical research
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., rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the worldHere, you have that opportunityYou 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 timeOur 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 packageTo discuss in more detail, please contact your hrbp or talent acquisition advisor.
New hires in office-based roles in the us & puerto rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for covid-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operationHowever, subject to applicable law, employees working in roles that the company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
Us and puerto rico residents only:
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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.
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Requisition id: r191431
Posted 5 days ago