Merck Clinical Research Manager in Montreal, Canada
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. With a diversified portfolio of prescription medicines, vaccines and animal health products, Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Right now, we are in the process of assembling our dream team—a group of scientifically diverse individuals inspired to invent in an environment of relentless curiosity and spirited collaboration. The best of the best. Is this you?
Clinical Research Manager
This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The CRM could be responsible for a particular study 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).
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, Merck 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 creating and executing a local risk management plan for assigned studies
Ensures compliance with CTMS, eTMF and other key systems in assigned studies
Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
Responsible 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 GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
As a customer-facing role, this position will build business relationships and represent MSD with investigators
Shares protocol-specific information and best practices across countries\clusters
CORE Competency Expectations:
Knowledge in Project/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 language. The incumbent must be competent and effective in written and verbal communication.
Behavioural Competency Expectations:
Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Merck Research Labs (MRL), Global Clinical Development (GCD) and GCTO
Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples 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
5-6 years of experience in clinical research of which 3 as CRA
Required: Bachelor degree in Science (or comparable)
Preferred: Advanced degree, (e.g., Master degree, MD, PhD)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. Merck is an equal opportunity employer, proudly embracing diversity in all of its manifestations.
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Job Clinical Research Generic
Title: Clinical Research Manager
Primary Location: NA-CA-QC-Montreal (Kirkland)
Requisition ID: CLI007944