Clinical study manager job description

We are looking for a Clinical Study Manager to provide assistance in the design, planning, and potential monitoring of clinical trials to ensure that studies are carried out according to the protocol, SOPs, applicable regulations, and principles of Good Clinical Practice.
Responsibilities:


Participates on clinical project teams and may represent clinical operations on multi-function projects teams internally/externally Assists in the preparation or review (if CRO engaged) of designated applicable documents required for the conduct of the study (Project Plan, Risk Management, Monitoring Plan, TMF), etc. Skilled at presenting information in a clear, concise manner to all levels within the department and contributing on a consistent basis to team initiatives in a thorough and timely manner.



Requirements:


Practical experience in clinical trial methods and processes; strong knowledge of clinical trial design. Knowledge of local and global regulatory pharmaceutical requirements and experience in providing timely and quality support of regulatory submissions. MUST have global experience, CNS Psychiatry a must; pediatric experience helpful. Needs experience managing CRO and site performance independently. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.


Pay range is $90 - $140 /hr depending on experience



Benefits
: Click here to learn more about benefits available to Eastridge s temporary employees. From time to time Eastridge s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply. Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring, the San Francisco Fair Chance Ordinance, and the Philadelphia Fair Criminal Record Screening Standards Ordinance (a copy of the notice of rights under the Philadelphia Ordinance is available by clicking on this link).

Title: Study Manager- Cell & Gene Therapy


Location: San Diego, CA (relocation assistance will be provided to candidates willing to relocate)
Duration: Direct Hire

Degree/Experience:
- BS degree with a minimum 5 years' or a Master's degree with experience in a lab setting is required
- Exp. Leading, Supervising or Managing other team members

"MUST HAVES":
- Exp. working with in vivo studies
- Exp. with typical and atypical dosing routes and sampling procedures
- AALAS certification, and/or additional related training are highly desired
- Exp. with preparation of Standard Operating Procedures (SOPs) and study protocols

"Nice to Haves":
- Exp. with ocular studies and procedures is a plus
- Exp. with Provantis is a plus
- Exp. in the technical writing of preclinical study protocols or reports will be considered a plus

Duties/Responsibilities:
- Responsible for oversight of in-vivo studies involving the testing of cell and gene therapy product
- Primary point of contact for clients to provide scheduling details and in-study updates.
- Work with the Account Managers and Study Directors to design studies that meet sponsors' needs in a scientifically sound and cost-effective manner.
- Address customer requests for information promptly and accurately.
- Follow internal processes for accurate record keeping of study designs, protocols, data, and reports.
- Preparation of study data, protocols and reports as needed
- Participate in the scheduling of studies to ensure appropriate resource management.
- Ensure that all study supplies are ordered and received in a timely manner.
- Lead kick-off meetings with the Study Directors and Research Associates to ensure proper study planning
- Key member of the Operations Team and functions as a liaison between the internal research scientists and account managers and our clients

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

• Bachelor's degree with a minimum of 5 years' or a Master's degree with experience in a lab setting is required.
• AALAS certification and/or additional related training are highly desired.

• Experience in the technical writing of preclinical study protocols or reports will be considered a plus.

Benefits:

Absorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

• Medical, Dental & Vision Insurance Plan with Employer Contribution
• Health Reimbursement Account Funded by Employer
• Healthcare & Dependent Care Flexible Spending Accounts
• Employee Life and AD&D Insurance 100% Employer Paid
• Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
• Short and Long Term Disability 100% Employer Paid
• 401k with Employer Match
• Employee Assistance Program

About Absorption Systems, a Pharmaron Company

Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) barriers in the development of drugs, biologics, and medical devices. Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situ and in vivo models to assess the properties in question. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.

Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally. We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers. Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation. The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals. Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.

Absorption Systems is proud to be an Equal Employment Opportunity and Affirmative Action employer.