Merck Clinical Research Director (CRD) - General Medicine (REMOTE) in Hartford, Connecticut

Job Description The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for GCTO country operations. Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster. The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage. CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities: Supports the regional GCTO leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement. Strategic country / cluster representative for initiatives at all levels of the organization. Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and our Research & Development Division objectives. Leads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division/ GCD Therapy Areas, and when appropriate Human Health. Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations. Leadership and Management of the GCTO country / cluster Organization: Recruits and hires talent. Proactively manages and develops talent. Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment. Creates an empowering, compliant, collaborative, and innovation-focused work environment. Builds a culture of quality and compliance through training, oversight, and collaboration. Oversight to ensure appropriate scientific and operational training for staff members. Clinical Operation Management: Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster. Leadership and oversight of the following: Our Research & Development Division/ GCD / GCTO goals, initiatives and expectations. Development and delivery of company standards in given geography. Activities of all cluster/country level GCTO team & all programs and studies. Approved administrative budget to support GCTO team (e.g., salaries & travel). Country level operational study budgets. Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs. Responsible and supports development of audit responses and completion of CAPAs. Extent of Travel : up to 30% CORE Competency Expectations: Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and our Research & Development Division 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 ICH GCP and Global/Regional/Local regulatory requirements is required. Strong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking. Behavioral 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 company's Research Labs, Global Clinical Development (GCD) and GCTO Positive proven success in people management. Experience: Required : At least 5 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. Preferred: A minimum of three (3) years of direct people management experience. Educational Requirements: Required : • Bachelor’s degree in Science or equivalent healthcare experience Preferred : • Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) 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 ( Current Contingent Workers apply HERE ( 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 ( 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 ( EEOC GINA Supplement​ Pay Transparency Nondiscrimination ( 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 ( 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: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed 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: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 08/14/2024 • 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: 08/14/2024 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: R306770 Source link Apply tot his job