Clinical Research Associate Manager (Remote)

Merck; Dover (DE); Remoto; USD 142.000 - 224.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an Associate Director to lead a team of 6-14 Clinical Research Associates in monitoring trials across countries, ensuring adherence to ICH GCP and SOPs.

You will develop talent, provide training and mentoring, manage performance, and coordinate with CRM, PLMs, and HQ resources to optimize site performance and capacity planning while collaborating with Vaccine/ Infectious Disease programs.

Competenze

• Minimum 5 years in Clinical Research.
• Minimum 3 years as CRA monitoring.
• Line management experience preferred.

Mansioni

• Oversee team of 6-14 CRAs and monitor study/site performance.
• Provide training, support and mentoring to CRAs.
• Coordinate with CRM, PLMs and HQ for capacity planning and resource allocation.
• Resolve CRA/site issues and ensure timely commitments with study CRM.
• Interface with GCTO partners on trial execution and escalate performance issues.

Conoscenze

People management

Clinical Research

Mentoring

ICH GCP

Trial management

Leadership

Communication

Formazione

Bachelor’s degree in Science

Advanced degree

Strumenti

Trial management systems

GCP documentation

Descrizione del lavoro

Job Description

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs)and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.

As Associate Director, the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder e.g. Clinical Research Managers (CRM) to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

This person will work primarily in Vaccine/Infectious Disease with some Cardiovascular therapeutic areas.

Responsibilities:

• Work allocation, staff development and performance appraisal.

• Support departmental company initiatives and workstreams.

• Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

• Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

• Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.

• Attend local Investigator Meetings if requested to.

• Interface with GCTO partners on clinical trial execution.

• Escalates site performance issues to Head of Site Management and Monitoring.

• People and Resource Management:

• Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

• Support and resolve escalation of issues from CRAs.

• Liaise with local HR and finance functions as required.

• Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

• Provides training, support and mentoring to the CRA to ensure continuous development.

• Ensures CRA compliance to corporate policies, procedures and quality standards

Qualifications, Skills & Experience

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

• 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

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 Requirements

Required

• Minimum of 5 years’ experience within Clinical Research

• Minimum of 3 years’ experience as CRA monitoring clinical trials

• Line management experience preferred or at the minimum team leader experience

Educational Requirements

Required

• Bachelor’s degree in Science

Preferred

• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

#eligibleforERP

#clinicaltrialjobs

Required Skills

Clinical Research, Clinical Research Methods, Clinical Study Management, Clinical Study Protocols, Clinical Trials Marketing, Conflict Management, Continuous Development, Data Reporting, Ethical Standards, Global Coordination, ICH GCP Guidelines, Liaison Work, Multiple Therapeutic Areas, Organizational Leadership, People Leadership, People Management, Performance Monitoring, Regulatory Compliance, Resource Allocation, Resource Deployment, Resource Planning, Site Operations, Situational Leadership, Standards Compliance, Study Monitoring

Preferred Skills

Cardiovascular Research, Infectious Disease, Infectious Disease Research, Line Management, Task Organization, Team Organization, Time Management, Vaccine Research

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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/)

The primary location for this posting is

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

50%

Flexible Work Arrangements

Remote

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a