Merck Clinical Trial Coordinator Manager (CTC Manager) - REMOTE in Tallahassee, Florida

Job Description This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally. Under the oversight of the CRD(Clinical Research Director) / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs(Clinical Trial Coordinator). As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance. The role will work across the different country operations roles (e.g. CRM(Clinical Research Manager), CRA(Clinical Research Associate)-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings. Train and oversee the CORE competencies, ICH‐GCP knowledge, Clinical Research environment 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, GTT 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, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners 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 CRA. Interface with GCTO(Global Clinical Trial Operations) partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery. Escalates site performance issues to CRM and CRD/TA-Head. People and Resource Management: Manages CTC – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions. Supports and resolves escalation of issues from CTCs. Manages capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work. Ensures CTC compliance to corporate policies, procedures and quality standards. Skills : Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager. Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding. of the pros and cons of each decision and takes ownership of decisions 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 required 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 ability to work within these guidelines Expertise in and excellent working knowledge of core trial management systems and tools. Strong coordination and organizational skills. 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 internal stakeholders and external partners. Fluency in both English and local language. Advanced Microsoft Excel skills for the purposes of data analysis Qualification & Experience: Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role. Line management experience preferred or at the minimum team leader experience. Educational Requirements: Required : Bachelor's Degree (or comparable) in Business Administration/ Life Science Preferred : Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration. #MRLGCTO #eligibleforERP 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. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) . 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 • 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: 05/28/2024 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: R295927 Source link Apply tot his job Apply To this Job