Clinical Study Manager

Requisition Number: 3033

Position Title: Clinical Study Manager

External Description:

SUMMARY:  The Manager, Clinical Study Management will provide support and oversight of all clinical trials conducted within the Early Phase Services Clinical Pharmacology Unit and will provide leadership to the Clinical Study Management team.
 
Tasks may include but are not limited to:

• Always represents Worldwide in a professional manner (verbal, written and in appearance) when interacting with Sponsors, volunteers, outside vendors, and fellow employees.
• Accountable for multiple team projects simultaneously.
• Effectively direct the delivery of projects within cost, time and quality requirements.
• Assign projects within the Clinical Study Management team.
• Provide direct supervision, support, training and mentoring to Clinical Study Managers.
• Lead study management team and facilitate their ability to lead the extended study team.
• Lead cross-unit coordination both internally and externally, inclusive of sub-contractors.
• Define and manage project resource needs.
• Promote effective teamwork among study team members.
• Resolve conflicts as needed.

Ensure appropriate communication on study-related matters with Sponsor and Site Management.

• Oversight study status and milestone achievement for client invoicing.
• Prepare and conduct performance appraisals and salary reviews, applies company policies.
• Works with leadership on the continuous development/improvement of business processes to ensure that work is uniform, complete and managed appropriately.
• Will act as a Clinical Study Manager and be the key client contact for studies/clients where required.
• Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence.
• Ensure that all staff allocated to assigned studies adhere to professional standards and SOPs established for clinical research.
• Performs additional assignments as warranted by upcoming and ongoing clinical research studies.
• Performs other duties as assigned.

 
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 
OTHER SKILLS AND ABILITIES:

• Experience in managing multiple studies/projects
• Strong leadership skills
• Strong financial acumen
• Excellent judgment and problem-solving/decision-making skills
• Knowledge of regulatory guidelines
• Demonstrated ability to handle multiple competing priorities and utilize resources effectively
• Demonstrated ability to inspire effective teamwork and motivate staff 
•  Excellent communication, planning, and organizational skills
• Strong interpersonal skills
• Ability to work independently
• Ability to negotiate and liaise with clients in a professional manner
• Good computer skills, and systems and application knowledge.
• Some knowledge and skills in performing technical and laboratory procedures.
• Possible physical demands include but are not limited to lifting and carrying of objects weighing 5-50 pounds.
• Excellent written and oral communication skills and attention to detail
• Ability to understand complex written and oral instructions. 
• Ability to set and meet multiple deadlines.
• Broad knowledge of drug development process and client needs
• Proven experience managing budgets and resources
• Available for domestic and international travel, including overnight stays
• Ability to drive and have a valid driver’s license
• Fluent in English, both written and verbal

 
REQUIREMENTS:
Required:            Bachelor’s degree in Life Science 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 seven (7) years of clinical pharmaceutical or CRO industry experience to include demonstrated skills and competency in clinical study management tasks. In lieu of the above requirements, candidates with > five (5) years of supervisory experience in a health care setting and six (6) years of clinical research experience in the pharmaceutical or CRO industries will be considered.
 
Other:                   Possible mental demands include, but are not limited to:  reading, math, intense concentration, verbal communication, written communication, and client contact, exceptional attention to detail, multi-tasks, frequent interruptions, and fluctuation in workload. 
                               Possible physical demands include, but are not limited to:  Extended periods of time at a computer; lifting and carrying of objects weighing 5-50 pounds; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Study 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.