Clinical Research Manager (CRM) Lead - Oncology/Early Development

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Our client seeks a senior Clinical Research Director to drive end-to-end performance of clinical trials in one or more therapeutic areas at the country level. You will oversee CRM teams, manage line responsibilities, and partner with local regulators to ensure global standards and local compliance.

With 10+ years in clinical research and 5+ years in leadership, you will develop talent, coordinate cross-functional teams, and maintain strong relationships with investigators and vendors.

Qualifications

• 10+ years of experience in clinical research with increasing responsibilities.
• 5+ years leading projects and teams in clinical trials.
• Bachelor degree in Science or comparable field.

Responsibilities

• Lead end-to-end management of clinical trials across one or more therapeutic areas.
• Oversee the CRM team and ensure performance, timelines, and quality.
• Ensure compliance with ICH/GCP, local regulations, and company SOPs.
• Develop operational strategies and risk management plans for studies.
• Collaborate with local and global stakeholders to align TA strategy and country needs.

Skills

Clinical Development

Clinical Research

Clinical Research Management

Clinical Trial Documentation

Clinical Trial Management

Education

Bachelor's degree in Science

Job description

This role will be key to further develop the country capabilities in clinical research. Under the direction of the country or cluster CRD/TA-Head the person will be responsible for the end-to-end performance of clinical trials in 1 or several Therapeutic Areas (TA), from feasibility to close out in 1 or several countries. The role will be responsible for oversight of the employees working in the TA, with line management of CRMs and functional oversights of other roles in their studies. At the discretion of the CRD/TA Head, the role could also be responsible for direct project work and will ensure excellent study performance with strict adherence to local regulations, our company's SOPs and ICH GCP. As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles. The role will work at country level with other local stakeholder like GMA, GHH, PV and regulatory to ensure alignment and development of the country capabilities and collaborates and works closely with other stakeholders in the TA in GCTO & GCD.

Responsibilities include, but are not limited to:

• Will lead 1 or several TA of the growing portfolio in the country.
• Accountable for the successful execution, enrollment and quality of their clinical trial portfolio.
• Accountable to ensure performance metrics, timelines and key milestones are met in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio.
• Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites.
• Ensures oversight and line management of Clinical Research Manager (CRM) team.
• Oversee the performance management and career development of staff and effectively manage performance issues.
• Lead a team independently with supervision from CRD/TAH to high performance.
• Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions.
• Ensures key talent development and retention.
• Collaborates internally with the cross-functional teams on local, regional and global level.
• Collaborates externally with investigators, regulators and vendors
• Supports strategic initiatives across country, Global Clinical Development GCD and GCTO.
• Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.
• Together with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance.
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• May act as a mentor.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head and Regional Operations.

Extent of Travel: Up to 30% of working time

Skills: Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level. Strong organizational skills with demonstrated success required. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments. Requires a complete understanding of ICH GCP and global/regional/local regulatory environment. Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape. Deep understanding of our research & development division organizational structure and cross-functional roles and responsibilities of its members. Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and execute complex protocols simultaneously. Experience functioning as a key link between Country Operations and Clinical Trial Teams. Communicates effectively and fosters a collaborative spirit in a remote/virtual environment and across countries, cultures and functions. Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity, quality and project and/or program delivery. Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly. Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking. Ability to work efficiently in a remote and virtual environment. The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations. Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience

Required:

• 10+ years of experience in clinical research with demonstrated success and increasing responsibilities of which 5+ years consisted of leading projects and team Bachelor degree in Science (or comparable)

Preferred:

• CRA Experience preferred
• Advanced degree, (e.g., Master degree, MD, PhD)
• Oncology / Early Development experience preferred
• #Eligibleforerp

Required Skills

• Clinical Development
• Clinical Research
• Clinical Research Management
• Clinical Trial Documentation
• Clinical Trial Management

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.

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 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

The salary range for this role is $142,400.00 - $224,100.00

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

The application deadline for this position is stated on this posting.

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