Job DescriptionOur 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 position manages all aspects of clinical trial operations in a country and will manage exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and CRO run studies. Will adhere to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies. The position will manage the trial quality, audit responses and the completion of Corrective Action and Preventive Action (CAPAs).The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across all phases within the country. The position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and company Research Labs staff in our 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 Human Health/Global Medical Affairs (GMA).Primary activities:
Provide Leadership to the country(ies): 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 company standards and Research Laboratory/Global Clinical Development (GCD) and GCTO goals, initiatives and expectations.
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 GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs).
Engage with Functional Service Provider (FSP) Senior, Regional and local team to ensure adequate and appropriate resourcing for the company's internal clinical trial portfolio.
Partner with Clinical Research Organization (CRO) Senior, Regional and local team to ensure the successful implementation of fully outsourced clinical trials - Work with the Global Operations group within GCTO and Global Medical Affairs as appropriate, in site management and selection decisions.
Develop and manage Investigator relationships in conjunction with the research laboratory 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 KOLs, etc.).
Manage clinical audit outcomes, working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
Represent GCTO 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 GCTO, GCD, and research laboratory objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s).
Represents the GCTO organization both internally and externally within the industry.
Ensure appropriate scientific and operational training for staff members.
Core Competency Expectations:
Significant Management background in a Clinical Trials setting with the ability to service and engage with different stakeholders within GCTO and research laboratory in a matrix organization.
Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.
Complete awareness of the International Conference on Harmonization Good Clinical Practice (ICH GCP) and Global/Regional/Local regulatory requirements is needed.
Strong communication skills requiring proficiency in written and spoken English.
Behavioral Competency Expectations:
High emotional intelligence.
Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, will enable and drive alignment with the goals, purpose and mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO.
Positive proven success in people management.
Strategic thinker.
Experience:
Minimum 10 years 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.
Educational Qualifications:
Required: Bachelor’s degree in life sciences combined with consistent contribution to and delivery of clinical trial execution.
Highly Preferred: Advanced degree (e.g. MA/MS, MD, PhD, Pharm D).
#EligibleforERPMRLGCTONOTICE FOR INTERNAL APPLICANTSIn 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/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.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 ModelEffective 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:$164,800.00 - $259,400.00Available 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 CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:RemoteShift:1st - DayValid Driving License:YesHazardous Material(s):NARequisition ID: R288138