Manager, Clinical Trial Coordinator

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Location :
Rahway, New Jersey

Expiry Date :
Tue, 15 Dec 2020 23:59:59 GMT

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Description :
Job_Description Our Clinical Research and Pharmacovigilance team pushes 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. Under the oversight of the Clinical Research Director (CRD), this position will manage a team of 8-18 Clinical Trial Coordinator (CTCs) and to ensure excellent study administrative performance with strict adherence to local regulations, company Standard Operating Procedures (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP). As line manager, the role is critical to continuously develop future talent by providing training and mentoring to the CTCs, as well as overseeing the Intern to Hire and Summer Intern candidate program while properly managing situations of low or non-performance. The role will work at the country level with other local stakeholders e.g. Clinical Research Manager (CRM) and CRD to ensure alignment and development of the country’s CTC capabilities. The role will engage with country Partner Line Manager (PLMs) and CRMs to ensure alignment across all monitoring therapeutic areas. The person contributes to CTC capacity/resource planning activities to ensure the efficient allocation of resources and work. Primary_Duties_Include,_But_Are_Not_Limited_To * Ensure and oversee proper on boarding and off boarding of employ compliance with initial and ongoing training. * Train and oversee the core competencies, ICH GCP knowledge, clinical research environment, monitoring etc. * Assure adherence to GCP guidelines, processes, and procedures related to direct reports activities and performance. * Ensure direct reports are compliant to the timelines and key business metrics. * Review and approve timesheets, Global Time Tracking compliance, expense reports, time off requests and provide proper oversight of CTC’s productivity/utilization. * Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources. * Work with CRDs, CRMs, CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability. * Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and Clinical Research Associate (CRA). * Interface with Global Clinical Trial Operations (GCTO) partners on clinical trial execution as assigned; acts as liaison with CTC Functional Service Providers partners in facilitating the coordinated process and product delivery. * Escalates site performance issues to CRM and Clinical Research Director (CRD). * People and Resource Management * Support and manage CTC career development, performance reviews, etc including addressing low-performance situations, and taking appropriate actions. * Manage and resolve escalation of issues from CTCs. * Contribute to Headquarter capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resources and work. * Ensures CTC compliance to corporate policies, procedures, and quality standards Core_Competency_Expectations * Ability to work independently and in a team environment * Excellent people management, time management, project management, and organizational skills * History of strong performance and leadership * Skills and judgment to be a good steward/decision-maker for the company * Fluent in Local Language and business proficient in English (verbal and written) * Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and the ability to work within these guidelines * Expertise in and excellent working knowledge of core trial management systems and tools Behavioral_Competency_Expectations * High emotional intelligence * Strong leadership skills with proven success in people management * Excellent interpersonal and communication skills, conflict management * Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators) * Influencing skills Experience_Needed * Minimum of 5 years within Clinical Research * Minimum of 3 years as CRA monitoring clinical trials * Background in line management or team lead preferred Educational_Qualifications * Required: BA/BS degree with emphasis in science and/or biology * Preferred: Advanced degree We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicine 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. 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. INVENT. IMPACT. INSPIRE. 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 package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. US_And_Puerto_Rico_Residents_Only If you need an accommodation for the application process please email us at For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations. 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 Regular Relocation: No relocation VISA_Sponsorship No Travel_Requirements 25% Flexible_Work_Arrangements Remote Work Shift 1st – Day Valid_Driving_License Yes Number_Of_Openings Hazardous Material(s): 1