Description
BiospecimentOperations Manager

Job 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.
• The following support may be required in the Central Repository (CR):
• 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.
• Support may be required in the following by Data Management (DM):
• 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.
Qualifications
Education Requirements
Min/Preferred Education Level Description
Additional Qualifications
• BA/BS in the biological sciences or related disciplines in the natural science/health care 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.
Critical Skills
Disclaimer
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its
sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents
may differ from those listed in the Job Description. The Company, at its sole discretion, will determine
what constitutes as equivalent to the qualifications described above. Further, nothing contained herein
should be construed to create an employment contract.
US ONLY
Years of experience required
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.
Physical Requirements: Position requires: ability to occasionally move about inside the office to access
filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary
position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office
items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer
and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and
assess written materials for prolonged periods of time; and ability to frequently communicate with
colleagues on the phone, by email, and in-person.
Work Environment: This job operates in a professional office environment. This role routinely uses
standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level
in the work environment is low. This is a largely sedentary role.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$79,800.00 - $139,600.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Summary
• Play a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution. • Serve as a member of the Translational Medicine clinical study start team; support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory documents and communicate information as required to other departments within Incyte and CROs (if appropriate); take part in program meetings with central lab, clinical, operations and data management. • Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation. • Particpiate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies, welcoming diverse perspectives, and inclusive practices. • Coordinate with others within Translational Medicine group and external to the group to track and manage samples, projects, and deliverables. • Aid in the process development and coordination of informed consent form tracking and clinical program sample storage/tracking using in-house and commercial systems. • Participate in vendor meetings to stay informed of current and upcoming projects, innovative technologies, and vendor offerings. • Solve problems independently, contacting internal or external clients as needed, while fostering a collaborative and inclusive environment. • Must be able to prioritize workload in response to the specific needs of numerous protocols and department. • Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples. • Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.