Crinetics Pharmaceuticals

Senior Medical Affairs Operations Manager

Remote, USA · Senior

Sponsorship not specified$147k-$184kDetected 91 days ago

GCPClinical TrialsFDA RegulatoryAnimal StudiesCommunicationCollaborationMicrosoft OfficeRegulatory Affairs

About the role

The Senior Medical Affairs Operations Manager is responsible for managing the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies and post-trial access programs.
The incumbent oversees the review, monitoring, and adherence to clinical protocols, taking ownership of key projects and working independently.
Essential Job Functions and Responsibilities:

Provide operational and strategic input into planning for expanded access programs and study specific documents such as synopses, protocols, ICFs, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plans, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
Coordinate and lead study team meetings and provide key stakeholders with updates on program progress including timelines, budget, and key milestones for the program.
Oversee TMF set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities.
Develop training materials for the program team, investigational sites, and vendors.
Manage information proactively by sharing with key stakeholders using standardized reports and other mechanisms.
Collaborate with counsel to negotiate and draft contracts and agreements with CROs/vendors and clinical sites, as needed.
Identify potential program issues and recommend and implement solutions or corrective actions as needed.

Some walking and lifting up to 25 lbs. may be required.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.
You may be required to travel for up to 10% of your time.

Bachelor's degree required, preferably in a scientific discipline.
Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience
at least 5 years in a supervisory role.
Experience managing clinical studies is preferred.
Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, and IRT and EDC systems.
Excellent understanding of the drug development process.
Able to make appropriate decisions to move the project(s) forward.
Effective verbal and written communication skills.

Develop the subject recruitment/retention strategy and related initiatives.
Assure programs are compliant with ICH/GCP and other regulations as appropriate.
Perform study risk management and implement mitigations.

The salary range for this position is: $147,000 - $184,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.

Environmental health and safety requirements also apply.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases.
We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives.
Our work continues to make a real difference in the lives of patients.
We have a prolific discovery engine and robust pipeline across preclinical and clinical development.
We are driven by science with a patient-centric and team-oriented culture.
This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients.
Come join our team as we transform the lives of others.

Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Crinetics is proud to be an Equal Opportunity Employer.
We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

tation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union s

This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.