Sample Manager, Clinical Research bei Wave

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:

The Sample Manager is responsible for overseeing the strategic development and implementation of a sample management plan. This includes ongoing tracking, storage, shipment, archival and final disposition of GxP biological samples which have been collected for exploratory analysis and preclinical studies conducted by or on behalf of Wave. The ideal candidate will ensure compliance with study protocols, regulatory guidelines, and quality standards as applicable to the tracking storage, shipment archival and final disposition of samples. The role involves cross functional collaboration with study teams, laboratory staff, and external vendors to manage the lifecycle of samples and maintain their integrity for research purposes.

Experience:

• Bachelors degree in Life Sciences, Biotechnology, or a related field
• At least 5-8 years of experience in regulated research environment including CTM or senior CTA type positions supporting clinical trials, or laboratory sample management
• Experience with biobanking, LIMS (or equivalent), and sample logistics is essential
• Sound understanding of clinical samples and their life cycle management is essential
• Understanding and experience of study sample collection, study lab manual preparation, sample shipment and storage is critical 
• Experience working cross functionally with diverse stake holders including speciality laboratory vendors is advantageous

Responsibilities:

• Accountable for overall sample management strategy and plan (including but not limited to sample management processes, procedures, vendors and documentation associated with the role)
• Proactive development of SOPs, systems and associated documentation to embed sample management practices at Wave and train stakeholders as needed
• Oversee and provide guidance on the correct receipt, labelling, tracking, and storage of biological samples (e.g., blood, tissue, saliva, etc.)
• Ensure proper documentation and inventory of all samples using Laboratory Information Management Systems (LIMS) or equivalent tools and/or implement an in-house sample inventory system and maintain tracking of in-house and external samples
• Participate and/or facilitate sample management process improvement initiatives
• Provide regular reports of sample storage at program and study level as required by stake holders
• Ensure sample management records are inspection ready at all times
• Manage sample access requests for all exploratory work at Wave
• Oversee sample destruction per regulatory guidelines
• Vendor selection, management and oversight

Compliance and Quality Control:

• Ensure compliance with regulatory standards (e.g., GCP, GLP, GDPR) and study protocols
• Conduct regular audits of sample processing and storage procedures and vendors
• Maintain quality assurance practices to prevent sample loss or degradation
• Participate in regulatory inspection readiness activities and regulatory inspections as necessary

Collaboration and Communication:

• Liaise with vendors to integrate the periodic reporting of sample status into the Wave sample management /LIMS system
• Provide training to study teams on proper sample collection and handling techniques
• Contributes to a seamless transition(s) and record management of sample ownership
• Act as a point of contact for resolving sample-related issues

Documentation and Reporting:

• Maintain accurate records of all sample-related activities, including deviations and corrective actions
• Prepare reports summarizing sample status, storage capacity, and utilization

Available to travel up to 25% when required.

Key Skills:

• Strategic leadership
• Excellent communication skills
• Excellent communication and problem-solving skills.
• Strong attention to detail and organizational skills.
• Knowledge of regulatory guidelines (e.g., ICH-GCP, ISO standards).
• Proficiency in Microsoft Office and database management tools.
• Financial and contractual management
• Vendor selection and oversight

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.