Assoc Mgr, CTA

Employer
Celgene
Location
San Diego, CA
Posted
Jun 13, 2018
Ref
1801694
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- CA- San Diego- Science Park


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope: Line manager for Clinical Trial Associates (CTAs)

Responsibilities will include, but are not limited to, the following:

1. Line management of Clinical Trial Associates (CTAs)

• Provide leadership, operational expertise and guidance as a point of escalation for clinical

operations coordination issues.

• Ensure that employees complete assigned project tasks on schedule and meet the

expectations of that project.

• Performance management: Tasks include and are not limited to tracking and monitoring

attendance/timesheets/expense reports; performing ongoing performance management

activities including individual goal setting/periodic performance assessments/timely

performance feedback/coaching/development planning and communication of

performance management assessments and any areas of concern to the Director, Clinical

Operations.

2. Resource planning, interviewing, hiring, training, mentoring, and personal development. Ensure

timely and optimal allocation of staff relative to priority of projects in collaboration with other

manager(s) and Directors to balance workloads across the study management group.

3. Foster a positive work environment and encourage professionalism in work behavior, work ethic,

mutual respect, innovation and accountability at all levels. Ensure that CTAs establish and

maintain optimal working relationships with Study Managers (SMs) and all Study Team

members, including vendors as appropriate.

4. Participate in strategic planning, development, and implementation for the group, tracking

timelines to remain in schedule, and developing contingency strategies, if needed.

5. Develop CTA training materials as needed and provide training and on-boarding to new hires.

Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation

across clinical trials.

6. Lead/participate in meetings to plan and implement operational activities to increase quality,

productivity, and efficiency of study management, Clinical Operations, CR&MA and Celgene.

Assist in streamlining processes and resolve complex operational problems.

7. Perform CTA activities as necessary, which include but are not limited to: processing essential

documents, drafting meeting minutes, tracking/generating investigator payments and subject

enrollment, ordering/tracking drug and study supplies, site feasibility, planning Investigator

meetings, preparing study materials including study management tools as necessary, reviewing

the TMF, drafting/reviewing functional procedures, EDC, CTMS, and assisting Clinical

Operations staff as needed in the support of studies. Assist with the preparation of reports; liaise

with investigational sites and regional monitoring group.

8. Collaborate and work effectively with other CTA/CSA managers to establish high quality

processes and ensure consistency and alignment throughout the team. Maintain clear lines of

communication with CTA/CSA managers to ensure high quality deliverables are met.

Skills/Knowledge Required:

• Excellent people interaction and communication skills, strong professional diplomacy and

positive attitude a must. Ability to foster a collaborative team environment, work in teams and

with various levels both within Celgene and with vendors as appropriate.

• Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multitask,

re-prioritize duties, and work effectively in a fast paced matrix environment.

• Knowledge of medical terminology. In depth understanding of clinical research and the US/

International regulatory environment. Strong computer skills to include MS Word, Excel and

PowerPoint.

• Minimum of 5 - 8 years experience as a CTA, CRA or equivalent in pharmaceutical or CRO

industry. Level of position dependent on experience.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.