Job Description
Our Clinical Research team pushes 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.
As a Clinical Research Director (CRD), you will be the Clinical Operations lead in the Nordic/Baltic cluster and will be responsible for execution of all Clinical Trials in scope for the cluster operations.
Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready clinical studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. You will ensure a single point of contact for managing clinical trial execution in all its aspects across phases in scope of Global Clinical Trial Operations within the Nordic/Baltic cluster.
The position is office-based and can be located in either Denmark or Sweden.
The CRD in the Nordics and Baltics is the primary cluster level contact for Global Clinical Trial Operations and has the following key responsibilities:
- Leads the regional Clinical Trial Operations leadership team, leading strategic development of Nordic/Baltic cluster to deliver clinical trials as per global clinical research pipeline requirement
- Strategic cluster representative for initiatives at all levels of the organization
- Build and lead the cluster team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the study portfolio across therapy areas and achieve on agreed objectives
- Leads strategic development and management of institutional & investigator relationships in conjunction with our company’s research division’s Therapy Areas
- Working with regional and global colleagues, develops and executes the Clinical Trial Operations strategy for the cluster - such as Industry associations
Leadership and Management of the Nordic/Baltic Clinical Trials cluster Organization:
- Recruits, hires, proactively manages and develops talent – in addition to creating an empowering, compliant, collaborative, and innovation-focused work environment
- Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment
- Builds a culture of quality and compliance through training, oversight, and collaboration
- Oversight to ensure appropriate scientific and operational training for staff members
Leadership and oversight of the following:
- Clinical Trial Operations and research division’s goals, initiatives and expectations
- Development and delivery of company standards in the Nordic/Baltic cluster
- Activities of all cluster level team & all programs and studies
- Country level operational study budgets
- Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs
- Responsible and supports development of audit responses and completion of CAPAs.
Collaboration, Supports and Engagement with Key External Stakeholders
- Functional Service Provider (FSP): Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio
- Clinical Research Organization (CRO): Senior, Regional and local Leadership to ensure the successful conduct of outsourced clinical trials as appropriate
- Support the development and management of Investigator and operational relationships in conjunction with all research division’s 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 Key Opinion Leaders etc.).
Quality / Compliance Adherence / Standard:
- Ensure that compliance, quality and timeline objectives are met for all trials executed in the cluster.
- Sets clear performance standards and holds self and organization accountable for achieving results.
- Work collaboratively in a matrix organization with all groups within Clinical Trials, especially with Clinical Sciences and Study Management in our US headquarters, Clinical Quality Managers and Regional Operations Teams, to deliver objectives
- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council.
Requirements:
Educational and Experience Requirements:
- Bachelor’s degree in Science or equivalent healthcare experience is required, advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) is preferred.
- 10 years or more of experience in Clinical Trials.
- 5 years or more of leadership experience.
Competency Expectations:
- Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders in a matrix organization.
- Strategic thinking
- 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. The incumbent must be competent and effective in written and verbal communication.
- 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.
- Positive proven success in people management
Application and further information:
You are welcome to apply online – application deadline is May 1st.
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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
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