Clinical Research Manager

hace 2 semanas

Santiago, Metropolitana, Chile MSD A tiempo completo

Job Description

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance and regulations, our company 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.
  • Reviews Monitoring Visits Reports and escalates performance issues and training needs. - Performs Quality control visits as required
  • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates 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
  • 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 pharmacovigilance and to align on key decisions in his/her studies.
  • 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 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
  • 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. Strategic thinking


Behavioural Competency Expectations:

  • Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our company Research Labs, Global Clinical Development and our Research & Development division.
  • 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


Experience Requirements:
Required:

  • 5-6 years of experience in clinical research of which 3 as monitor
  • +1 year as a CRM (or at least 3 to 6 months minimum as an acting CRM)
  • Advanced English


Educational Requirements:

Required:

  • Bachelor degree in Science (or comparable)

Preferred:

  • Advanced degree, (e.g., Master degree, MD, PhD


Your role at our company 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. In our company, we're inventing for life.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/11/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/11/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R296845

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