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Sampling Oversight Manager
Sampling Oversight ManagerImmatics • Hartford, CT, US
Sampling Oversight Manager

Sampling Oversight Manager

Immatics • Hartford, CT, US
18 days ago
Job type
  • Full-time
Job description

Join Immatics and Shape the Future of Cancer Immunotherapy

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Why Join Us?

Innovative Environment : Help to pioneer advancements in cancer immunotherapy.

Collaborative Culture : Be part of a diverse team dedicated to your professional growth.

Global Impact : Contribute to therapies that make a lasting impact on patients globally.

Sampling Oversight Manager

We are seeking a Sampling Oversight Manager to support our Clinical Operations team. The Sampling Oversight Manager will be responsible for overseeing the complete lifecycle of clinical trial samples, including collection, tracking, analysis, reporting, and destruction, while ensuring compliance with protocols and regulations. The position serves as the primary contact for trial teams, managing lab operations, reconciliations, and queries, while collaborating cross-functionally to define testing requirements, maintain sample logs, and develop processes, SOPs, and training materials.

FLSA Classification : Salary, Exempt Schedule : 8 : 00 AM 5 : 00 PM; Monday to Friday Reports to : Sr. Manager, Team Lead Sample Oversight Location : Fully Remote

What You'll Do :

As a Sampling Oversight Manager, you will play a key role in supporting our clinical operations :

Tracking of all clinical trial samples (from sample collection until destruction, incl. clinical trial samples at external clinical trial testing labs)

Ensuring the maintenance of a global clinical trial sample log, tracking the sample status

Query Management for clinical trial samples at Immatics internal clinical trial testing labs

Performing Lab Reconciliation in collaboration with Immatics internal clinical trial testing labs and Clinical Data Manager

Oversight of operational activities throughout the clinical trials related to clinical trial samples within Immatics internal clinical trial testing labs (incl. sampling, storage, transfer, analysis, reporting, current challenges, workload, risks, issues)

Primary contact for clinical trial teams related to Immatics internal clinical trial sample management

Reporting of global clinical trial sample status to clinical trial teams

Oversight of operational close-out activities related to Immatics internal clinical trial sampling and analyses

Develop and maintain internal processes, SOPs, guidance documents & training materials related to clinical trial sampling matters.

Collaboration with internal and external Functional Leads (i.e. Clinical Operations Lead, Correlative Studies Lead, Translational Lead, any Sample Owner, etc) to define clinical trial specific clinical testing requirements (e.g. sample collection timepoints, sample type and volume, sample labelling, analysis method, sample shipment, storage and destruction)

Collaboration with Clinical Outsourcing Manager and Clinical Operations Lead for external central laboratory selection

Collaboration with internal Functional Leads (e.g. Clinical Operations, Immatics Laboratory groups, Correlative Studies Lead, Sample Logistics, Clinical Data Manager) to agree on internal and external clinical trial testing labs, analysis frequency and result reporting

Oversight of operational set-up and change activities at Immatics internal clinical trial testing labs related to clinical trial sampling and analyses, compliant to the signed clinical trial protocol, signed contract and other clinical trial specifications

Required Experience and Education :

At least Master's Degree, preferably with exposure to sample management procedures within the GCP / GCLP / GLP area or equivalent

At least 2 years of project management experience in the pharmaceutical / biotechnology industry, preferred in laboratory related functional area

Advanced leadership skills and strong team player

Proactive attitude with strong sense of responsibility within own scope

Intermediate presentation skills and advanced organizational skills

Full reflection on complex process structures and connections

Proficient verbal and written communication skills in English with high degree of tact and diplomacy

Strong ability to identify, deeply analyze and communicate problems

Analytical reasoning and good project management skills

Comprehensive understanding of priorities within own scope with limited interaction with the supervisor

Proactively driving company standards, global harmonization and innovation in own scope

Proactively driving quality and efficiency to meet timelines and milestones in own scope

Fostering innovation and development in own area

High degree of flexibility in an environment which is marked by a constant striving for excellence

Competencies :

Intermediate organizational skills to structure own tasks and predefined working packages

Ability of need and room for improvement within own scope

Work Environment :

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.

Travel required : Willingness to travel if necessary for business reasons.

Physical demands :

Communicating Verbally expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.

Hearing the ability to hear, understand, and distinguish speech and / or other sounds one-on-one, group or conference, telephone, and other sounds.

Keyboarding entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object usually by holding it in the hands or arms but may occur on the shoulder.

Near Visual Acuity clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

Pushing - exerting force upon an object so that the object moves away from the object.

Pulling - exerting force upon an object so that the object moves toward the force.

Sitting remaining in a sitting position for at least 50% of the time.

Standing / Walking - remain on one's feet in an upright position at a workstation.

Stooping occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Work authorization / security clearance requirements : Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action / EEO statement : Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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Manager • Hartford, CT, US

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