[Z796] Clinical Research Director - Argentina

[Z796] Clinical Research Director - Argentina

17 dic
|
Msd
|
Bogotá

17 dic

Msd

Bogotá

Clinical Research Director - Argentina This job is available in 8 locations Job Type Full time Saved Jobs This site is for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific.Residents of the United States, Canada & Puerto Rico, please . JOB DESCRIPTION Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world.

And 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.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.The role of the Clinical Research Director manages all aspects of clinical trial operations in the country and is responsible for exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations of an interventional nature and CRO run studies.Adherence to local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is responsible for trial quality and audit responses and completion of targets. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the country/cluster. The position has multiple touch points with our clinical trials team and our research facilities staff in the US headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Global Human Health & Global Medical Affairs.Primary activities:- Provide Leadership to the country: Build the best team and chart the course.This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Adhere to our organization's standards and the units goals, initiatives and expectations. Participate and support the goals and objectives of the Leadership Team. Speak with “one voice” on agreed strategies.- Manage Clinical Operations activities and personnel within the country/cluster. Ensure that compliance, quality and timeline objectives are met for all trials executed in the country. - Work collaboratively in a matrix organization with all groups within our clinical trials organization, especially with Clinical Sciences and Study Management, Clinical Quality Managers and if applicable the Regional Operations Center, to deliver objectives - Collaborate with Functional Service Provider Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for the our clinical trial portfolio- Collaborate with Clinical Research Organization Senior , Regional and local Leadership to ensure the successful implementation of fully-outsourced clinical trials - Work with the Global Operations group and Global Medical Affairs as appropriate, in site management and selection decisions. - Support the development and management of Investigator relationships in conjunction with the Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with key opinion leaders, etc.). - Take responsibility for any clinical audits, working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council.- Represent the team and the country on strategic initiatives at all levels of the organization. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s) - Represents the clinical research organization both internally and externally within the industry - Responsible for ensuring appropriate scientific and operational training for staff members.CORE Competency Expectations: • Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within clinical research and medical research laboratories in a matrix organization.• Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery• A complete understanding of Global/Regional/Local regulatory requirements is required.• Strong Communication skills requiring proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.• Strategic thinkingBehavioral Competency Expectations:• High emotional intelligence• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our research, clinical development and clinical trials teams.• Positive proven success in people managementExperience Requirements:Required:• 10-15 years of experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.• English proficiency is a mustPreferable: Experience with Oncology researchEducational Requirements:Required:• Master’s Degree with a proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizationsPreferred: advanced graduate degree (e.g., an MD, PhD, Pharm D, MS,)Who we are … We are known as Merck & Co., Inc., Kenilworth, 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 … 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 come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.Current Employees apply Current Contingent Workers apply 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 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: RegularRelocation:No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings: 1Requisition ID:R156207 Email this job to: Your name Recipient’s Email address Success! Your email is on its way... Failure! Email has not sent Media player About Us We are one company, but we operate under two different corporate brand names. We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else. COVID-19 Learn more about our virtual hiring process and new hybrid work model. Total Rewards Discover how we support our employees’ well-being to help them fulfill their potential. Be Yourself Our culture values a diversity of voices and always bringing your best self to work. 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