Provides scientific oversight and clinical guidance for projects within the Medical Surveillance Team (MST). Interacts with senior management, customers, and project teams to ensure scientific integrity and data quality in clinical trials. Provides scientific input as needed to projects outside the MST and contributes to business development activities. Has direct line management and mentoring responsibilities.
1. Applies clinical and scientific expertise to all duties, including but not limited to mentoring, staff and site training, MST touch point design, data reviews, site interactions, and proposal development.
2. Develops and maintains a professional, collaborative, and clinically oriented relationship with the investigators and their staff.
3. May perform any or all of the following duties depending on the MST services provided in the assigned project:
a) Works with Investigators and their staff in order to ensure that they understand the specifics of the protocol, particularly surrounding diagnostic and clinical scales;
b) In collaboration with the MST project team and Medical Monitors, reviews screening data and leads case reviews to determine whether subjects are appropriate for entry into a trial;
c) Follows up with Investigator regarding any diagnostic, ratings, or other assessment-related questions that may arise during review of proposed subjects or general study data;
d) Tracks and evaluates rating scale scores and other study endpoints for logic, quality, validity, and reliability. Monitors rating scale and assessment data for quality issues that should be discussed with Investigator;
e) Performs and/or evaluates statistical reviews of data to address reliability and validity questions;
f) Works with any vendors or Company staff involved in the training on the use of clinical scales or diagnostic instruments; assists in determining the qualification and remediation of selected raters.
4. Trains the MST staff in the therapeutic area under study and applicable instruments.
5. Works with MST project team and leadership to design MST touch point reviews and process planning.
6. Works with MST project team and Business Unit leadership to develop medical surveillance plan documents, budgets, timelines, and other supportive documents
7. Presents MST materials and plans at kick-off meetings, quick-start camps, investigator meetings and other internal or sponsor meetings as necessary.
8. With guidance from a more senior Clinical Scientist and MST Director, supports the Business Development Department and Business Unit by providing information and/or slide presentations covering MST capabilities, patient populations, and activities. Presents on behalf of MST at Customer capabilities and bid defense meetings.
9. Lends clinical expertise and guidance to project teams within Business Unit as needed.
10. May perform Project Director or Project Manager tasks as needed.
11. May have line management responsibilities for one or more staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Note: If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template.
Skills & Attributes
Doctoral level degree relevant to therapeutic area (e.g., for CNS: Clinical Psychology PhD or PsyD or Psychiatry MD) or equivalent education and experience. Moderate to extensive clinical experience with patients in relevant therapeutic area. Extensive proficiency with medically accepted diagnostic approaches relevant to therapeutic area (e.g., ICD, DSM). Moderate knowledge of common diagnostic and assessment instruments relevant to therapeutic area. Good knowledge of psychometrics, inferential biostatistics, and medical terminology. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Excellent written, interpersonal, and presentation skills. Excellent attention to detail, accuracy, and organizational skills. Ability to perform several tasks simultaneously to meet deadlines preferred.
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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
For employees in the United States ONLY
FLSA status: Exempt
Years of experience required: Minimum of one (1) year of clinical or related experience.
Physical Requirements: Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.
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.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
INC Research is an EEO, M/F/D/V and a drug-free workplace. INC Research voluntarily participates in the federal E-Verify work authorization program.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to firstname.lastname@example.org . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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INC Research - 17 months ago
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