Senior Clinical Job Description
Senior clinical
provides interpretation and guidance, with instruction by Global Clinical Auditor/line manager/mentor, for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards.
Senior Clinical Duties & Responsibilities
To write an effective senior clinical job description, begin by listing detailed duties, responsibilities and expectations. We have included senior clinical job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
Monitor (remotely) clinical study data entered in an Electronic Data Capture (EDC) system or paper case report form at sites to ensure regulatory and protocol compliance overall accuracy
Identify and share recruitment best practices
Coach interviewers on interviewing and candidate assessment techniques
Interview prospective employees and evaluate candidates
Gather candidate feedback from interview teams and assists in leading the final assessment and selection process
Develop salary recommendations, inclusive of, when appropriate, sign-on bonuses, relocation, long term incentive programs, and annual bonus
Provide company information to candidates
Clinical study execution within the Cardiovascular & Specialty Solutions group and the overall Clinical Center of Excellence
Fostering strong, productive relationships with colleagues within the organization
Senior Clinical Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Clinical
List any licenses or certifications required by the position: ASCP, MLS, MT, CCRA, CCRP, CPR, PMP, HTL, HT, BS
Education for Senior Clinical
Typically a job would require a certain level of education.
Employers hiring for the senior clinical job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Nursing, Healthcare, Medical, Health Care, Life Sciences, Science, Life Science, Business, Pharmacy
Skills for Senior Clinical
Desired skills for senior clinical include:
Clinical research process
Budget management
Electronic data capture
GCP
Medical terminology
FDA regulations
Federal
Current GCP/ICH guidelines applicable to the conduct of clinical research
State and third-party reimbursement rules and regulations
IDX system
Desired experience for senior clinical includes:
Serving as a member of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility
Overall execution of small-medium regulated and non-regulated clinical projects or large non-regulated clinical projects including, but not limited to, study planning, initiation, budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure
Providing support to department wide training
Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects
Leading several small/medium clinical studies (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff
Assisting with the management of large regulated studies under supervision of CPM or Senior CPM and May support CPM and/or Senior CPM within a large or complex clinical study
Senior Clinical Examples
1
Senior Clinical Job Description
Job Description Example
Our innovative and growing company is hiring for a senior clinical. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior clinical
- Provides training and education sessions regarding GNE brand(s) and their approved indication(s)
- Partners with clinical specialists in other ways/means by attending periodic account meetings
- Supportcollaboration of multiple disciplines and working relationships with corporate departments, divisions, and facility
- Supportproject teams in integrating CPOE and Order Set activities into their project plans
- Assist with training, mentoring, and development of junior employees, co-monitoring
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
- Report, write narratives and follow-up on serious adverse experiences
- Participate in the development of protocols and Case Report Forms as assigned
- Participate in writing clinical trial reports as assigned
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
Qualifications for senior clinical
- Must have demonstrated ability to lead PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion
- Knowledge of standard business procedures (regulatory guidance, global regulations, SOPs)
- Ability to effectively present information to and respond to questions from groups of managers, sites
- Bachelor degree & above, clinical medicine would be preferred
- Strong people communication skill
- Good project management skill ( good planning, implementation and follow up) is required
2
Senior Clinical Job Description
Job Description Example
Our growing company is hiring for a senior clinical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior clinical
- Ensures clinically integrated, patient centric care coordination with a focus on appropriate first PAC setting, appropriate PAC LOS, transitions of care and readmission avoidance
- Supports the concept of being a data driven organization, relying heavily on analytics and outcome reports to drive the business
- Conducts weekly team call with all team members
- Interviews, hires, and is ultimately responsible for the competency and compliance of all clinical field staff
- Directly supervises the Clinical Team Manager (CTM)
- Works with CTM to maximize colleague performance using nH based reports, audits, record reviews and field based observations
- Participates in MMR, reviews results with CTM and creates action plans for identified issues
- Conducts semi -annual and annual colleague performance reviews
- Supports the CTM in rounds facilitation, field staff observations, colleague recognition and coaching when needed
- Works with Market Leadership and Human Capital to determine staffing requirements to support work volume
Qualifications for senior clinical
- Registered nurse or clinical experience strongly preferred
- Is an expert user of patient care related information systems (preferred Cerner Millennium)
- Requires strong analytical and statistical skills and interpretive abilities to make recommendations for improvements or changes
- Significant clinical research/CRA experience including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out
- Understanding of scientific process medical and statistical concepts
- Ability to resolve project-related problems and prioritize workload for self and team
3
Senior Clinical Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior clinical. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior clinical
- Collaborates with Network Manager to develop business relationship with local providers
- Works directly with the GM to review market performance and develop/refine clinical strategy to maximize KPI achievement
- Evaluates performance to benchmarks, goals and outcomes for all programs high cost, volume and risk conditions
- May makes recommendations on reporting and analytic needs of the market
- In conjunction with the GM, attends and participates in the JOC meetings
- Functions as a liaison to the Local Physician Champion (LPC) to manage readmissions and other in market needs
- Develops relationships with client/partner peers at the hospital and plan level
- Monitors Compliance to Implementation Protocols and/or Contract SLA
- Works collaboratively with the Health Services and Utilization Management departments and programs to ensure positive outcomes
- Monitors feedback from member satisfaction surveys and provider feedback and identifies process improvement opportunities
Qualifications for senior clinical
- Ability to understand and work with financial information
- In lieu of the above requirements, candidates with four (4) years of site management and/or registry administration experience will be considered
- Able to develop knowledge of the disease under study
- Able to develop knowledge of protocol, regulatory guidelines and requirements, and company SOPs
- Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect
- This position requires a Bachelor's degree with 5 years successful experience as a systems user representative or analyst
4
Senior Clinical Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior clinical. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior clinical
- Lead life sciences customers in the rapid configuration and implementation of applications to support clinical trial and content management needs in the form of the Vault Clinical suite (Vault CTMS, Vault eTMF, Vault Study Startup, Vault Investigator Portal)
- Define strategies and implementation program(s) for deploying the Vault Clinical suite across an organization globally
- The ISCS will develop performance assessment tools such as workflow diagrams, site profile summaries, and cycle/response time charts
- The ISCS will be able to organize and manage full system clinical training classes on key Synapse components
- The ISCS will be able to understand, develop, train and explain in detail the Synapse product development road maps
- Confirms appropriate management of investigational product by performing drug reconciliation and accountability and other related -Review research specimen sample shipments to central lab
- On-going review of site regulatory file for completeness and accuracy
- Track and report progress of study, including activities
- Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements
- Assist in the planning and coordinating investigation meetings
Qualifications for senior clinical
- Experience leading projects and directing the efforts of multiple people is preferred
- Experience should include 1 year working in a health care environment in a clinical role
- 5-7 years’ patient care delivery experience as a Board Certified / Board Prepared Oncologist
- Advanced degree or equivalent education/degree in life science/healthcare strongly recommended if no previous experience in clinical research
- Involvement in cross-functional, multicultural and international clinical trial teams
- 10+ years’ direct experience working with clinical software solutions in clinical operations, TMF operations, and/or trial management
5
Senior Clinical Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior clinical. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior clinical
- Assist in recruitment of subjects for minimal risk studies
- Order and maintain supplies required for study procedures
- Blood sample handling and storage
- Maintain a database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs
- Maintain Trial Master File up-dated
- Support Clinical Team
- File and maintain the study administrative files locally and send original documents to central TMF
- Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams
- Ensure full integration of statistics and statistical thinking into our daily research, product and process development, technology transfer and production
- Develop robust products, processes and analytical methods for products in the pipeline in alignment with the Quality-by-Design principles
Qualifications for senior clinical
- Identify variants associated with human phenotypes and interrogate human causal biology
- PhD in field related to Pharmacokinetics
- Demonstrates technical expertise on PK/PD projects
- Knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to document and data collection
- Proven track record leading high-impact global system implementation programs for life sciences as a consultant, business or IT lead and/or business sponsor for clinical systems
- Proven ability to manage diverse stakeholders, and ensure delivery to a high degree of satisfaction