medical writer

clinical research associate

site manager

medical writing manager

regulatory affairs specialist

Syneos Health

Reviewed and adhered to the requirements of study-specific Clinical Data Management Plans which met sponsor specifications.
Co-developed and contributed to the compilation of Clinical Data Management Plan documentation and clinical database user testing documentation as requested by the Lead Data Manager.
Prepared test data for user testing of database screens and edit checks.
Participated in study specific data entry training and services as backup to data entry staff
Performed clerical and administrative support tasks for the CDM group.
Performed clinical study data review as required by Clinical Data Validation Plans.
Managed data discrepancy process to ensure discrepancies were generated and resolved in a satisfactory and timely manor as part of the study team.
Utilized CRF WorkManager to process discrepancies/DCFs.
Verified database changes as requested by LDM.
Updated clinical database based on queries, site generated DCFs, discrepancy management guidelines, and performed other database changes as directed by an experienced study data manager and in accordance with established guidelines.
Prepared relevant subject data files for internal audits and quality control.
Maintained proficiency in use and analysis of data entry system and performed systemic data management review tasks and overall awareness of CDM practices by reading related literature, attending training classes, professional meetings and participating in project specific training sessions.
Functioned as the Lead Data Manager in the absence of the LDM.
Attended regional seminars and provided CRF completion training to study coordinators.
Created Data Entry Guidelines.
Co-developed study specific Clinical Data Management Plans which supported sponsor specifications.
Participated in internal and sponsor team meetings.
Mentored and trained new or less experienced team members.
Performed Clinical Data Associate I duties as required.

inVentiv was OK, although I don't believe they fought for most of us to transition us to new contracts once current ones ended.  My ERM told me Iroko was a cheap company and only learned their lesson once they saw attrition soon after launching Zorvolex.    There was a company wide raise soon thereafter to reduce attrition.  Not sure Iroko really did their homework or laid the groundwork for these products to succeed. 

Furthermore, there was questionable use of copay cards by reps that lead to many being paid inflated bonuses when the company was in fact losing money on each and every script filled.  This was Iroko managements fault for not forseeing this but worse for letting it continue.  Iroko finally had to shutdown numerous districts due to an inability to crack formularies in many parts of the country.  But they had to redistribute the sales force numbers due to the contract with inVentiv.   Many reps invited to join Iroko were paid well and given stock options (possibly worthless now, I think...), but have now all been laid off.

Both my Iroko manager (Iroko employee) and my inVentiv manager (ERM) were great people who I knew no one had issues with.

I spoke with a number of inVentiv managers who said the Iroko contract was generally reviled within inVentiv because they were cheap and did not appreciate the work they had to do to facilitate the reps jobs or the fair pay they deserved.  

inVentiv, along with Touchpoint, Quintiles & Ashfield, are going to be major rep employers as companies try to use this model to hire people without having the fear of ending contracts or dismissing reps without the need to pay severance.  Welcome to the 21st Century!

Syneos Health was formerly INC Research when I first started and was a good place to work and I had wonderful managers. Then my project ended--the last few years I worked there, I was assigned to a new project with poor management, working 70+ hours/week, and managers didn't even try to keep me regional (unless you call the entire United States my region). There were no opportunities for me to advance as a Sr. CRA. My line manager was also the study manager so when challenges arose, I had no one to advocate for me. It became a very stressful environment and I left. I want to be clear that i left the manager and not the company. Syneos overall is a good place to work--good salary, benefits, quarterly bonus opportunities,  401K, and generous PTO after a few years of working for them. However,  due to constant monthly deadlines, it got to be difficult to take any PTO which also made me very unhappy after putting in long work weeks on an every week basis. Manager never came out even once to do a site visit with me or anyone else on the team. This is a definite management failure as i never even met the manager in person and the manager seems to have forgotten the many difficulties and challenges that CRAs face on a daily basis. Some people should not be in management. The hard lesson learned--your manager will either make or break you. I'm glad I left for my sanity's sake but I do regret not leaving sooner as things never got better as i hoped they would.

Most employees are swamped with work from early morning to late night. If you show any proficiency in your ability to do the work, you are subsequently overloaded with tasks and expected to complete the workload of more than three individuals. Each day your schedule is flooded with multiple 1hr+ long meetings, which greatly hinders your ability to get your actual work completed so you are forced/expected to work 50+ hours per week (abysmal work-life balance). Sites and clients are chronically unhappy so if you are at all interested in ensuring customer satisfaction... please find another CRO to work for. Management does not care about the employees as they are simply seen as disposable cogs. Most upper management does not understand how to perform the job of their own subordinates which frequently results in policy and procedural changes that are more detrimental than at all helpful. The culture, on the face, is "we're all one big family", but in reality you are promised the world and given a singular saltine in a cafeteria full of "mean girls" with rampant gossip and all the back-biting you can handle. The most enjoyable part of the job was other employees, at some point you become "fellow soldiers" in the trenches simply trying to survive the barrage of nonsense together.

Syneos Health is a great place to start your career - you are exposed to a wide variety of fortune 500 pharmaceutical clients in a multitude of capacities, and you are encouraged to work across teams to expand your skill set. Office has a very casual environment, direct managers are very supportive and encourage personal growth and development. 

Unfortunately, the organization lacks structure in upper management. Most complaints or inquiries from smaller, younger teams are only heard by direct management and do not get any further up the ladder. There is also a lack of career trajectory - you are able to get exposure and experience in various projects (which is incredibly valuable in itself), but in terms of title change and career growth, opportunities are limited. Annual review process is extremely drawn out, tedious, and inefficient. 

Generally, office has a nice culture, very smart people, and fantastic opportunities to learn more about healthcare, pharmaceuticals, patient advocacy and policy. It is a great place to start your career and get your feet wet, but definitely not to stay for several years and expect to grow.

a typical day at work is stressful for all the wrong reasons. I was forced to cancel customer in-service appointments for spontaneous training calls on a topic such as Concur. 
 
middle management is not engaged and often negative. Rushes off the phone or cancels 1:1s.  My first impression of my direct manager was him expressing his overwhelming dissatisfaction and desire to quit. 

Work culture discussion seems to be for show.
I was taught the culture was to readily be available 24/7 because as the contract says, this is not a 9-5 job. I have had work assigned up to and past midnight with early morning customer calls not long after. 

Often, no one knows what’s going on, even when it comes to important pay out information, etc. HR has no idea what is going on behind the manager’s scenes. HR leadership ignored my emails requesting guidance on serious matters.

There are some solid people I met at Syneos.
 Great trainers. Young, motivated reps who are ready to learn. I plan on staying connected with them for the rest of my career. 

I had an annual review and my feedback was on the BRAND of my detail bag.

The most enjoyable part of the job is providing value to our customers. Where the focus should be.

After working here, I have learned a lot, gained valuable experience and truly need therapy.

This place is the epitome of a poor work environment. Most people are miserable and complain to each other behind closed office doors. Directors are a dime a dozen but they all think they're God's gift to clinical research and will do anything they can to get ahead, especially throwing their direct reports under the bus. Most departments are heavily micromanaged and even check on attendance by reviewing your badge history (when did you swipe your badge to get in...that sort of thing.) For awhile there were also people who came around twice a day to take attendance. Management said it was to see how office space was being utilized but we all know better than that. The only people who advance here are the people who suck up to management...so I guess if you lack self-pride then it should be easy! It doesn't help morale when there is cut, after cut, after cut. I've been through 4-5 different rounds of layoffs and have only been here for a little over a year. If you're not desperate for a job then do yourself a favor and look somewhere else.

My typical day at INC on a 6 month contract (that was extended many times) was interacting with my lead and line manager daily which was very helpful as there was a consistent open communication that contributed to the success in achieving the INC and Sponsor's expectations.  The workplace culture was excellent in the beginning and the flow of the study was running smoothly up until the last weeks before my contract ended as we needed to meet the timelines as per the Sponsor's directives. This became the hardest part of the job as I was working well over 70 hours per week and the pressure coming from upper management created a very stressful work environment  that I am still recovering from. Overall I enjoyed the contract and do understand why INC added the pressure to meet deadlines. What I did not care for was the way INC ended my contract with only one day notice just before the holidays right after they had everything they needed from me.
The lesson learned was that as a contractor I must be prepared to be treated this way simply as a hired contractor and not to take it personally.

A typical day would include managing about ten clinical trial cases at different stages of processing: initial entry, quality assurance review, medical review, sponsor review, edits by sponsors, follow-up queries, and correspondence. My previous experience had been with post marketing cases that were being litigated, so working on clinical trial SAEs was a new learning experience. My co-workers were great sources of information and just plain good people. The managers were good at their jobs, but many times overloaded the data safety associates with extra cases, causing associates to work overtime on the weekends with no additional pay. The hardest part of the job was learning the job, as training was lacking in many areas, and busy managers, who did not want to take the time to show associates how to do something, simply referred us to a manual. The most enjoyable part of the job was creating a great narrative, and enjoying the friendship and expertise of my safety associate co-workers!

The cost of health care is skyrocketing. Thanks to the Sunshine Act, pharmaceutical companies are now limited in their financial self-promotion and fund monies to increase their bottom line. 
The time is now for curtailing the upswing in communities newly susceptible to Hep C and other infectious diseases and seeing they get education and awareness on risk factors and self-care as well as get treated. Legislative policy is needed. And  passion is to work with communities and addressing the existent discrepancy in health care.                                                                                                                                                        

As a community advocate focused on giving to diverse and vulnerable populations, I integrate social responsibility, relate to the community, and take the time and care to dig deep for data that will help serve our communities. I will create local relationships, handle budgets and develop programs while taking into account the need for initiatives for training patients in self-care, which is the underlying source of patient health. My goal is to help the health care community devise equitable programs for vulnerable populations that will ensure a safety net of financial resources in the face of present and new epidemics.

Top Job Titles	Average Salary
Medical writer 523 salaries reported	$130,429 per year
Clinical research associate 139 salaries reported	$99,951 per year
Site manager 158 salaries reported	$98,658 per year
Medical writing manager 157 salaries reported	$144,326 per year
Regulatory affairs specialist 147 salaries reported	$63,450 per year

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