BiospecimentOperations Manager

Syneos Health • USA-DE-Client, DE

3d • $79,800 - $139,600 • Onsite

About The Position

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Requirements

• BA/BS in the biological sciences or related disciplines in the natural science/healthcare field or Registered Nurse. B. Tech or N. Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience.
• Clinical Data Management experience with experience particularly of handling LLNR data.
• Extensive experience with local laboratory data collection methods and management of LLNR data in clinical trials.
• Expert knowledge of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials.
• Strong knowledge of medical terminology.
• Strong project management skills and demonstrated staff leadership skills.
• Contract Research Organization (CRO) experience.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Excellent organizational, planning, and time management skills required. Ability to multitask under tight deadlines while providing attention to detail.
• Able to demonstrate critical thinking with strong attention to detail.
• Experience in change management.
• Experience to work independently as well as part of a multi-disciplinary team.
• Proven experience in making effective decisions and manage multiple priorities in a highly dynamic environment.
• Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management and local laboratory data management.
• Experience in dealing effectively with sponsors and internal customers.
• Responsible for performing activities in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management.
• Understand budget and identify out of scope LNR activities.
• Experience in reviewing and testing eDC Database LNR component.
• Knowledge of ALCOA++ data quality principles.
• Minimum of seven (7) to ten (10) years of laboratory experience and preferably with two (2) to three (3) years of clinical data management experience.

Nice To Haves

• B. Tech or N. Dip Biomedical Technology preferred where applicable in lieu of degree

Responsibilities

• Quality check data received via Service Now (SNOW) to ensure accuracy of information.
• Identify annual updates on local Lab normal Ranges LLNRs based on their effective dates.
• Check LLNR against protocol required analytes and notify the CDLS team when there are changes to the project (e.g., Protocol Amendment) that impact the LLNR.
• Assess availability of local labs as required by a project; Verification of LLNR data entered; Generating protocol specific LLNR export and QC of export prior to entry in clinical database.
• Entry and filing of LLNRs and Logical Observation Identifiers Names and Codes (LOINC); Review/resolve issues in the clinical database via query management; QC LLNRs entered; Review LLNR/LOINC listings; create additional listings within the Data Validation Specifications (DVS); Design eCRF and testing (UAT) of database with Local Lab component.
• Create, present, and oversee training/mentoring of new team members, current team (or other functional areas as required) on local lab data, LLNRs/LOINC.
• Conduct/document quality reviews on members onboarding to prove competency on all Clinical LLNR tasks.
• Resolution of LLNR/unit conversion issues with Biostatistics and Medic as applicable.
• May act as Process owner for the LLNR procedures/templates, serve as clinical laboratory data Subject Matter Expert (SME) and POC for delivery of LLNR related tasks across a portfolio of studies.
• May support the Proposal Development team in creating the DM Budget specific CDLS activities.
• Required to attend and/or participate/support in Trusted process meetings, internal/external inspections/audits and resolving Quality Issues (QIs) focusing on the management of the LNR and LOINC data.
• Actively support the CDLS management team in: Global collaboration of CDLS team across countries; Oversight of initiatives and process improvement tasks; Collation of Productivity, Quality and KPI metric reports and analyzing metrics to identify risks/deploy preventative actions; review project deliverables and support assignment of CDLS team across the global TA BU portfolio; Implementation of new regulatory requirements related to local laboratory management; Manage LLNR/LOINC completeness and provide metrics on status to study teams/executive leadership.

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level