Clinical Research Manager

Requisition Number: 1303

Position Title: Senior Manager, Study Conduct

External Description:

SUMMARY:  The Clinical Research Manager, Study Conduct, under the supervision and guidance of the Site Director is responsible for assuring that all members of the Screening and Coordinating teams and Nutrition Department are trained, prepared, and informed about managing their respective components of a clinical research trial. In addition, he/she will be responsible for working as a team with other departments in the conduct of a clinical trial. The Senior Manager, Study Conduct directly supervises the Screening Manager, Nutrition Supervisor, Coordinators, and Assistant Coordinators.

 RESPONSIBILITIES:

Tasks may include but are not limited to:

• Works closely with organizing and planning clinical trials in new therapeutic areas or with new procedures.
• Works closely with other department Managers and Supervisors to facilitate study-related communications and teamwork assuring all staff performs necessary duties. May need to develop new systems to assure needs from all departments are met.
• Oversees all the studies running simultaneously to assure they are conducted and enrolled most efficiently. May require planning between different Coordinators and other departments
• Hires, trains and supervises Screening Manager, Nutrition Supervisor, Assistant Coordinators, and Coordinators.
• Project staffing needs in advance to assure adequate staffing for all studies.
• Provides operational expertise and guidance to the staff. QCs and signs timesheets for staff as well as approve any scheduled time-off.
• Sets up coverage for staff when on vacation, out sick, etc.
• Assigns staff to studies, visits, and duties as needed.
• Updates WIs related to Senior Manager, Study Conduct’s expertise as needed, but at least annually.
• Trains PRN, part-time and full-time staff on assigned WIs.
• Trains Coordinating staff to manage clinical studies, including working visits with trainees.
• Works with Screening Manager to ensure Research Associates are trained in the Informed Consent and Screening process.
• Trains Nutrition Supervisor on protocol review of dietary requirements, menu creation, and food ordering processes.
• Oversees the writing, training, and annual updates of a Coordinator’s Training Manual.
• Responsible for ensuring the correct payment of subjects. May include responsibility for petty cash.
• Assures all Direct and Indirect reports have completed mandatory training promptly. May need to organize training sessions with other departments or from an external source.
• Ensures all required training is completed and thorough documentation is on file before an employee under your supervision performs any job-related duties.
• Keeps a good rapport with all Investigators and gets their input on the performance of managed teams.
• Creates documents as needed, including menus, for study conduct.
• QCs source documents before being used in a study, as necessary.
• Meets regularly with reported staff. This time can be used to discuss time management, future work, to discuss problems and solutions, “retrain” on certain duties, etc.
• May be required to coordinate a study during peak times.
• Covers study procedures or shifts as needed.
• Attends and assists with study initiation meetings, sponsor site visits, tours, and any audits.
• Assures departmental timelines are met with a high-quality product delivered.
• Meets with Sponsors/Monitors to gauge clinic performance.
• Additional assignments as warranted by upcoming and ongoing clinical research studies as well as staff.
• Responsible for requesting, scheduling, and attending any training required for this position. Perform other duties as assigned.  

 OTHER SKILLS AND ABILITIES:

• Experience in managing projects in a multi-office environment
• Demonstrated ability to handle multiple competing priorities; utilize resources effectively
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
• Demonstrated ability to lead by example and to encourage team members to seek solutions
• Excellent communication, planning, and organizational skills
• Self-motivated and excellent problem-solving skills
• Strong interpersonal skills
• Ability to work independently
• Ability to forecast potential problems in multiple departments
• Ability to negotiate and liaise with clients in a professional manner
• Good computer skills.    
• Possible equipment includes, but is not limited to: microscope, computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, and allergy testing equipment, scales, calculators, vital signs equipment, ECG equipment, and other medical equipment.

 REQUIREMENTS:

Required: University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities.

 Preferred: Minimum of five (5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical study/project management tasks. Preferably within the Phase I environment. Minimum of 5 years of line management experience

 Other: Thorough knowledge of project management processes. Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development program. Available for domestic travel, including overnight stays

REQUIREMENTS (Cont.):

Other: Valid current passport required, to address the need for infrequent international travel if necessary.Ability to drive and have a valid driver’s license. Fluent in local office language and in English, both written and verbal.Broad knowledge of drug development process and client needs

 Possible mental demands include, but are not limited to:  reading, math, intense concentration, verbal communication, written communication, client contact, attention to detail, multiple tasks, frequent interruptions, fluctuation in workload, etc.

Other: Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals. 

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City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Research Manager

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.